PRODUCT CATALOG 2014/15

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DENTAL RATIO stands for high quality at constantly fair prices – made in Germany, by Hager & Meisinger. Our success is based on this consistent concept.

And our users can rely on it. Many thanks for believing in us! Welcome to

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OKTAGON Implant system 9

OKTAGON

®

_{TISSUE LEVEL}

TISSUE LEVEL Implants and Restoration options 10

Indications TISSUE LEVEL 12

SURGICAL TISSUE LEVEL RP

TL RP Implants Ø 3.3/Ø 4.1/Ø 4.8 mm 14

TD Implants Ø 4.1 mm 20

PROSTHETICS TISSUE LEVEL RP

TL RP Standard 22

TL RP Solid Abutments 26

TL RP Ball Attachments 26

TL RP ALLIGATOR 28

SURGICAL TISSUE LEVEL WP

TL WP Implants Ø 4.8 mm 30

PROSTHETICS TISSUE LEVEL WP

TL WP Standard 32

OKTAGON

®

_{BONE LEVEL}

BONE LEVEL Implants and Restoration options 34

Indications BONE LEVEL 36

SURGICAL BONE LEVEL NC

BL NC Implants Ø 3.3 mm 38

PROSTHETICS BONE LEVEL NC

BL NC Standard 40

BL NC ALLIGATOR 42

SURGICAL BONE LEVEL RC

BL RC Implants Ø 4.1/Ø 4.8 mm 44

PROSTHETICS BONE LEVEL RC

BL RC Standard 48

BL RC ALLIGATOR 50

ACCESORIES

OKTAGON®_{Instruments and Tools} ₅₂

OKTAGON®_{Surgical kit mini} ₅₄

OKTAGON®_{Surgical kit} ₅₆

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GENERAL INFORMATION

USE OF PRODUCTS

Users of DRS International GmbH (hereinafter referred to as DENTAL RATIO) dental implants, and the other products distributed by DENTAL RATIO, must have knowledge of these products and information on how to handle them safely and expertly as described in the instructions for use.

DENTAL RATIO products must always be used in accordance with the instructions for use provided. The user is obliged to use the product according to these instructions and ensure that it is indicated for the patient’s specifi c situation.

AVAILABILITY

Some of the DENTAL RATIO products shown in this document may not be available in all countries.

VALIDATION

Upon publication of this catalog, all previous versions cease to be valid.

PRODUCTION

Made in Germany by Hager & Meisinger, a guarantee for high-grade medical products over the past 125 years.

PRODUCT INFORMATION

Further information on DENTAL RATIO products is available from your local sales representative or the download section at http://www.dental-ratio.de

TRADEMARKS

OKTAGON®_{is a registered trademark of DRS International GmbH.}

NOTE

All details – descriptions, drawings or pictures in this product catalog are simply intended to describe the products and are non-binding. DENTAL RATIO assumes no liability for the veracity of the information. Changes and errors remain reserving.

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T

IS

S

U

E

L

E

V

E

L

RP Regular Platform Ø 3.3 mm Ø 4.1 mm Ø 4.8 mm TD Tapered Design Ø 4.1 mm Ø 4.8 mm WP Wide Platform Ø 4.8 mm Ø 6.5 mm

B

O

N

E

L

E

V

E

L

NC Narrow Connect Ø 3.3 mm Ø 3.3 mm RC Regular Connect Ø 4.1 mm Ø 4.8 mm Ø 4.1 mm Ø 4.8 mm

COLOR CODES

Yellow Endosseous implant diameter 3.3 mm

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SYMBOLS

g

Batch number

h

Article number MIX Verpackung FSC® _C007413

GFA certifi cation symbol denoting compliance with the

Forest Stewardship Council for product packaging (FSC®_{) standard.}

IK

Gamma rays with at least 25 kGy (2.5 Mrad)

L

Only sterile if the packaging is undamaged

C

0044

xxxx identifi es the notifi ed body of the manufacturer

Y

Store the packaging appropriately

D

For single-use only

i

Please refer to instructions manuel

H

Shelf-life: 5 years. Use before: YYYY-MM

℞ only

CAUTION: Federal law (U.S.A.) restricts this product_{to sale by or on the order of a dentist or physician}

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WWW.DENTAL-RATIO.DE

0044

0824

PRODUCED BY MADE IN GERMANY HAGER & MEISINGER GMBH, WWW.MEISINGER.DE

ETIKETT 50 x 25 mm

IK

L

Y

D

i

H

Nur zum einmaligen Gebrauch For disposable use only Pour usage unique Para uso unico

Gebrauchsanweisung beachten! Consider directions for use! Remarquez le mode d’emploie! Ver manual de usario! Haltbarkeit 5 jahre, verwendbar bis Valid for 5 years, expiry date Durée de stérilité 5 ans, utilisable jusque Periodo canucidad 5 anos, ultizable hasta Gammastrahlen mit mind. 25 kGy (2,5 Mrad) Sterilized with gamma radiation min. 25 kgy (2.5 mrad) Stériliser par rayons gamma min. 25 kgy (2,5 mrad) Esterilizado con rayons gamma minimo 25 kgy (2,5 mrad) Nur steril, wenn Packung unbeschädigt

Sterility not guaranteed if package is broken Uniquement stérile, si l’emballage intact Solo esteril si el embalaje no esta defectuoso

Rot, wenn sterilisiert Red, if sterilized Rouge, si stérile Rojo, cuando esta esterilizado

Packung sachgerecht lagern Store under appropriate conditions A stocker correctement Almacenar embalaje adecuadamente

onl

y

VORSICHT: Gemäss dem US Bundesgesetz dar

f

d

ieses Produkt nur an ausgebildete Mediziner ode

r

i

n deren Auftrag verkauft werde

n.

C

AUTION: Federal law (U.S.A.) restricts this produ

ct

t

o sale by or on the order of a dentist or physici

an .

OKTAGON

®

OKTAGON

® MI X V erpackung FSC ® C007413 ETIKETT 50 x 25 mm MI X V erpackung FSC ® C007413 ART.NR 84DRSOKT01

TISSUE LEVEL

REGULAR PLATFORM

TL RP

TL R P GENERAL RP OKTAGON Implant Ø 4.8 mm L=12 mm 1 pc. h 50348 _g AXXXXX H 2018-08 Ø 4.8 mm L 12 mm RP 4.8 mm Ø 4.8 mm L 12 mm RP 4.8 mm

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is specialised in dental implantology and supplies patent-free pro-ducts at economical prices for maxillofacial surgeons, oral surgeons, dental practitioners and dental technicians – including a broad range of prosthetic solutions.

BUY SMART

is the DENTAL RATIO motto and stands for the link between high product quality and the intelligent use of resources and procedures for cost-effective products. Our aim is to improve the healthcare and quality of life of as many patients as possible by providing them with high-grade, yet fairly priced, dental medical products.

QUALITY – MADE IN GERMANY

Our objective is the development, optimisation and supply of high-grade medical-technical materials and procedures. Well-known specialists in implantology provide DENTAL RATIO with professional and scien-tifi c counselling and support.

Together with Hager & Meisinger, a manufacturer renowned for proven quality, DENTAL RATIO generates advantageous prices which are passed straight to the customer.

Within the highly specialised and constantly growing implantology/surgery market, professional compe-tence and acceptance by users are decisive factors for the long-term success of our systems.

REASONABLE PRICES FOR

DENTAL PROFESSIONALS AND PATIENTS

Considering the continually increasing costs in the healthcare system, high quality products at fair prices play a vast role in providing good healthcare. The economic effi ciency of DENTAL RATIO benefi ts dental professionals and patients.

COMPETENT COUNSELLING

Our team has many years of experience in oral implantology. We use our entire expertise to advise you according to your own specifi c needs.

ADDITIONAL PRODUCTS

To extend the surgical and prosthetic possibilities we offer the following add-on products:

• SafeScraper®

• COREFLON PTFE Suture

• LOCATOR®_{Hybrid prostheses restoration}

• DESS Products • ALTUS™

Further product information can be found at http://www.dental-ratio.de/downloads

REGENERATION

The team at DRS International GmbH would be pleased to provide you with information on the

NanoBone®_{product line with regard to new dimensions in bone augmentation.}NanoBone® _{is a}

syn-thetic bone substitute and bone augmentation material respectively. The secret of its success lies in the high performance nano structure: nano crystalline hydroxylapatite (HA) is embedded into an extremely porous silica gel matrix.

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Tissue Level implants are connected to the prosthetic restoration via an 8° inner cone with additional octagonal rotation stop.

Bone Level implants are connected via a 15° inner cone and internal grooves whereby an octagonal geo-metry of the abutment secures the prosthetic components in position.

* Data on File REM (x 5000) endosteal surface sand-blasted and acid etched

The macro-roughness exhibits a roughness profi le of 20 to 40 µm with micro-roughness of 2.0 to 4.0 µm.

The surfaces in the endosteal section are sandblasted with corundum (> 99% Al₂O₃ = aluminium oxide)

and acid-etched.

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TISSUE LEVEL OVER

VIEW

* Cover screw 31154 sterilized incl.

** Cover screw 93730 sterilized incl.

OKTAGON

®

_{TISSUE LEVEL IMPLANTS}

TISSUE LEVEL · TL

RP Ø 3.3 mm L 8.0 mm 72186* Cover -scr ews Healing abutments GH 2.0 mm 35683 L 10.0 mm 72187* small 31154 GH 3.0 mm 35736 L 12.0 mm 72199* large 31155 GH 4.5 mm 35751 L 14.0 mm 72267* RP Ø 4.1 mm L 8.0 mm 31151* Cover -scr ews Healing abutments GH 2.0 mm 35683 L 10.0 mm 31152* small 31154 GH 3.0 mm 35736 L 12.0 mm 31153* large 31155 GH 4.5 mm 35751 L 14.0 mm 82647* RP Ø 4.8 mm L 8.0 mm 50125* Cover -scr ews Healing abutments GH 2.0 mm 35683 L 10.0 mm 50347* small 31154 GH 3.0 mm 35736 L 12.0 mm 50348* large 31155 GH 4.5 mm 35751 L 14.0 mm 50550* TD Ø 4.1 mm Healing abutments GH 2.0 mm 35683 L 10.0 mm 38150* Cover -scr ews small 31154 GH 3.0 mm 35736 L 12.0 mm 38415* large 31155 GH 4.5 mm 35751 WP Ø 4.8 mm L 8.0 mm 93727** Healing abutments GH 2.0 mm 93731 Cover -scr ews small 93730 L 10.0 mm 93728** GH 3.0 mm 93732 L 12.0 mm 93729** GH 4.5 mm 93733

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RESTORA

TION OPTIONS

1)_{Bar restoration}

on 4 implants

2)_{As bridge abutment,}

splinted with an implant Ø 4.1/4.8 mm

1) 2) 2)

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INDICATIONS TISSUE LEVEL

Implant-Ø _{3.3 mm} _{4.1 mm} _{4.8 mm} Lengths mm 8 10 12 14 8 10 12 14 8 10 12 14 Platform RP x x x x x x x x x x x x RP/TD x x WP x x x

REGULAR PLATFORM (RP)

OKTAGON®_{3.3 mm Ø RP implants are an alternative option for cases with a minimum jaw width of}

5.5 mm and a mesiodistal gap of at least 7 mm between adjacent teeth.

As their mechanical strength is lower than that of the 4.1 mm Ø implants, these implants should only be used for the following indications:

EDENTULOUS JAW

4 Implants Ø 3.3 mm RP in combination with a bar.

PARTIALLY DENTATE JAW

Fixed restorations on 4.1 mm Ø implants should be splinted with a superstructure.

OKTAGON®_{Implants Ø 4,1 mm RP are an alternative option for cases with a minimum jaw width of 6.0}

mm and a mesiodistal gap of 7.0 mm between adjacent teeth.

OKTAGON®_{Implants Ø 4.8 mm RP are an alternative option for cases with a minimum jaw width of 7.0}

mm and a mesiodistal gap of 7.0 mm between adjacent teeth.

SPECIFICATIONS RP REGULAR PLATFORM

Implant-Ø mm 3.3 4.1 4.8 Platform-Ø mm 4.8

¦

|

¦

|

¦

|

||

¦

|

¦

|

¦

|

¦

|

Height mm 1.8 Polished Neck

Pitch mm 1.0 1.25 1.25

Outer-Ø mm 3.3 4.1 4.8 Inner-Ø mm 2.8 3.5 4.2

TISSUE LEVEL INDICA

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fl exible soft tissue management.

INDICATION

Mostly for immediate (same day as extraction) and early implantation (6-8 weeks post extraction).

SPECIFICATIONS TD REGULAR PLATFORM

Implant-Ø mm 4.1 Platform-Ø mm 4.8

¦

|

¦

|

¦

|

||

¦

|

¦

|

¦

|

¦

|

Pitch mm 0.8

Outer-Ø mm 4.8

Inner-Ø mm 3.5

WIDE PLATFORM (WP)

OKTAGON®_{Implants Ø 4.8 mm WP are for cases where the jaw exceeds 7.0 mm in width and a}

mesio-distal gap of 8.5 mm between adjacent teeth.

They are mainly indicated for restoring teeth with wider diameter cervical sections and are suitable for broader alveolar ridges and interdental spaces.

SPECIFICATIONS WP WIDE PLATFORM

Implant-Ø mm 4.8 Platform-Ø mm 6.5

¦

|

¦

|

¦

|

||

Pitch mm 1.25

TISSUE LEVEL INDICA

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TISSUE LEVEL SURGICAL

RP

TISSUE LEVEL SURGICAL

TL RP IMPLANT Ø 3.3 mm

Cover screw sterilized 31154 incl.

Regular Platform Ø 4.8 mm · Height Polished Neck 1.8 mm

Implants Gauges Drills

Endosseous Ø 3.3 mm Parallel pins Round bur (max. 800 min−1)

72186 Ø 3.3 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

72187 Ø 3.3 mm L 10.0 mm Pilot drill and drill extension see page 30

72199 Ø 3.3 mm L 12.0 mm

72267 Ø 3.3 mm L 14.0 mm

Depth gauge Twist drills (max. 800 min−1₎

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

Twist drills (max. 600 min−1₎

38149 Ø 2.8 mm, L 33 mm

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TISSUE LEVEL SURGICAL RP

Countersinks Instruments Cover screws

and Healing abutments

Countersinks (max. 400 min−1₎ _{Taps (max. 15 min}−1₎ _{Cover screws}

Ø 2.8 mm, L 25 mm 95267 Ø 3.3 mm, L 33 mm 31154 small 72268 Ø 3.3 mm, L 42 mm 31155 large Healing abutments 35683 GH 2.0 mm 35736 GH 3.0 mm 35751 GH 4.5 mm

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RP

TISSUE LEVEL SURGICAL

TL RP IMPLANT Ø 4.1 mm

31151 Ø 4.1 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

31153 Ø 4.1 mm L 12.0 mm

82647 Ø 4.1 mm L 14.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

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RP

TISSUE LEVEL SURGICAL

TL RP IMPLANT Ø 4.8 mm

50125 Ø 4.8 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

50348 Ø 4.8 mm L 12.0 mm

50550 Ø 4.8 mm L 14.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

38136 Ø 3.5 mm, L 41 mm

38151 Ø 4.2 mm, L 33 mm

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RP TD

TISSUE LEVEL SURGICAL (TAPERED DESIGN)

TL RP/TD IMPLANT Ø 4.1 mm

38150 Ø 4.1 mm L 10.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

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TISSUE LEVEL SURGICAL RP TD

und Healing abutments

93740 Ø 3.5 mm, L 37 mm 95264 Ø 4.1 mm, L 23 mm 31154 small 31155 large Healing abutments 35683 GH 2.0 mm 35736 GH 3.0 mm 35751 GH 4.5 mm

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TISSUE LEVEL PROSTHETICS RP

STANDARD

Impression 31156 open tray 63978

Single crown _Model

64551 31157 64553 31158 Impression 55283

}

* closed tray 84957 31164

}

* 31166 31160 screwed 82648 82649 82689 63978 31160 Single crown 64551 38118 64553 38117 38122 38123 cementable 38124 38125 82689 31161

}

* 31163

* only to use combined

TISSUE LEVEL PROSTHETICS

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ABUTMENTS ANGLED VERSIONS

A

+

B

Choice of optimal version for individual care

TISSUE LEVEL PROSTHETICS RP

31156 TL RP Impression cap with

integral guide screw (open tray)

82649 TL RP Abutment angled, 15° B

H 6.7 mm, screwed/cementable

integral guide screw (closed tray)

38117 TL RP Abutment angled, 15° B H 6.7 mm, cementable, parallel 55283 TL RP Impression cap (snap-on) 38123 TL RP Abutment angled, 15° B H 6.7 mm, cementable, conical

84957 TL RP Positioning cylinder red 38119 TL RP Abutment angled, 20° A

H 6.7 mm, cementable, parallel

31157 TL RP Implant analog 38124 TL RP Abutment angled, 20° A

H 6.7 mm, cementable, conical 31161 TL RP Abutment, H 5.5 mm cementable 84960 incl. 38116 TL RP Abutment angled, 20° B H 6.7 mm, cementable, parallel 84960 TL RP Basic screw for 31161 38125 TL RP Abutment angled, 20° B H 6.7 mm, cementable, conical 31162 TL RP Plastic coping bridge/bar for 31161

82689 TL RP Plastic shoulder for

Abutment, angled, 15°/20° 31163 TL RP Plastic coping crown for 31161 40100 TL RP Abutment, excl. 31025 2 pcs. multifunctional (PSU) 31164 TL RP Abutment H 1.5 mm, screwed 31025 TL RP Fixation screw HEX/OKT for 40100 31165 TL RP Plastic coping bridge/bar for 31164 57040 TL RP Abutment Titanium-adhesive base 31166 TL RP Plastic coping crown for 31164 57041 TL RP Abutment

Titanium-adhesive base, incl. 57042

82648 TL RP Abutment angled, 15° A H 6.7 mm, screwed/cementable 57042 TL RP Basic screw for 57041 38118 TL RP Abutment angled, 15° A H 6.7 mm, cementable, parallel

57043 TL RP Basic screw for

CAD/CAM

38122 TL RP Abutment angled, 15° A

H 6.7 mm, cementable, conical

31160 TL RP/WP Occlusal screw

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TISSUE LEVEL PROSTHETICS RP

STANDARD

Impression 31156 open tray 63978 Telescope/Bar _Model 64551 31157 64553 31158 Impression 55283

}

* closed tray 84957 31164

}

* 31166 31160 Telescope 40100 31025 57041 63978 57042 Hybrid 64551 64553 31164

}

* 31165 31160 Bar 40100 -31025 57040 57041 57042

* only to use combined

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TISSUE LEVEL PROSTHETICS RP

ABUTMENTS ANGLED VERSIONS

A

+

B

Choice of optimal version for individual care

integral guide screw (open tray)

82649 TL RP Abutment angled, 15° B

H 6.7 mm, screwed/cementable

integral guide screw (closed tray)

38117 TL RP Abutment angled, 15° B H 6.7 mm, cementable, parallel 55283 TL RP Impression cap (snap-on) 38123 TL RP Abutment angled, 15° B H 6.7 mm, cementable, conical

84957 TL RP Positioning cylinder red 38119 TL RP Abutment angled, 20° A

H 6.7 mm, cementable, parallel

31157 TL RP Implant analog 38124 TL RP Abutment angled, 20° A

H 6.7 mm, cementable, conical 31161 TL RP Abutment, H 5.5 mm cementable 84960 incl. 38116 TL RP Abutment angled, 20° B H 6.7 mm, cementable, parallel 84960 TL RP Basic screw for 31161 38125 TL RP Abutment angled, 20° B H 6.7 mm, cementable, conical 31162 TL RP Plastic coping bridge/bar for 31161

82689 TL RP Plastic shoulder for

Abutment, angled, 15°/20° 31163 TL RP Plastic coping crown for 31161 40100 TL RP Abutment, excl. 31025 2 pcs. multifunctional (PSU) 31164 TL RP Abutment H 1.5 mm, screwed 31025 TL RP Fixation screw HEX/OKT for 40100 31165 TL RP Plastic coping bridge/bar for 31164 57040 TL RP Abutment Titanium-adhesive base 31166 TL RP Plastic coping crown for 31164 57041 TL RP Abutment

Titanium-adhesive base, incl. 57042

82648 TL RP Abutment angled, 15° A H 6.7 mm, screwed/cementable 57042 TL RP Basic screw for 57041 38118 TL RP Abutment angled, 15° A H 6.7 mm, cementable, parallel

57043 TL RP Basic screw for

CAD/CAM

38122 TL RP Abutment angled, 15° A

H 6.7 mm, cementable, conical

31160 TL RP/WP Occlusal screw

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TISSUE LEVEL PROSTHETICS RP

SOLID ABUTMENTS

81038 81083 81096 55668 55283 55288 Single crown Solid abutments

55299 Bridge 55394 72088 55396 55397 55400 Crown 55487 Bridge 55478

BALL ATTACHMENTS

38087 38071 82758 Hybrid Driver 38073 89611 89612 89613

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81038 TL RP Solid abutment yellow, 6°, H 4.0 mm 55283 TL RP Impression cap (snap-on) 81083 TL RP Solid abutment grey, 6°, H 5.5 mm 55288 TL RP Positioning cylinder yellow 81096 TL RP Solid abutment blue, 6°, H 7.0 mm 55299 TL RP Positioning cylinder grey

55478 TL RP Plastic coping for

solid abutment, bridge

55394 TL RP Positioning cylinder

blue

55487 TL RP Plastic coping for

solid abutment, crown

55396 TL RP Solid abutment analog

yellow

55668 TL RP Solid abutment driver

6°, L 15 mm, (S)

grey

72088 TL RP Solid abutment driver

6°, L 21 mm, (M)

blue

Article-No. Product Article-No. Product

38087 TL RP Abutment

ball attachment GH 0.0 mm

82758 TL RP Matrix for ball

attachment (incl. all O-Rings)

38071 TL RP Implant analog

for ball attachment

89611 TL RP O-Ring 70 shore red

Pull-off weight light

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TISSUE LEVEL PROSTHETICS RP

ALLIGATOR

2010.601 Impression 31156 Model 31157 2010.611 63978 64551 2010.701 64553 2010.702 Hybrid 2010.731 2010.710 2010.711 Impression 2010.722 2010.712 Model 2010.721 2010.713 2010.714 2010.715 2010.725 2010.731 98001 2010.741 0° 98002 98003 2010.751 98004 75836 2010.703 Hybrid 2010.723 2010.724 63978 64551 2010.101 64553 15° 98007 98008

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TISSUE LEVEL PROSTHETICS RP 98003 TL RP ALLIGATOR Abutment GH 3.0 mm 64551 OKTAGON®_Screwdriver one-piece, L 24 mm 98004 TL RP ALLIGATORAbutment GH 4.0 mm 75836 TL/BL ALLIGATOR Attachment driver, L 15 mm

NOVALOC

_™

S W I S S M A D E

2010.731 Demounting tool for mounting inserts + model analogue reposition aid, blue

2010.741 Mounting and demounting tool for retention inserts, brown 2010.751 Matrix housing extractor

grey

2010.703 Titanium matrix housing 4 pcs.

with attachment option incl. PEEK mounting insert

incl. PEEK mounting insert

2010.702 PEEK matrix housing 4 pcs.

2010.725 PEEK mounting insert 4 pcs.

black

2010.721 Model analog 4 pcs.

Aluminium

2010.722 Forming/fi xing matrix, red 4 pcs.

PEEK

2010.723 Processing spacer, white 4 pcs.

POM C 2010.101 Equipment box

with 3 tools

(excluding consumables)

2010.601 Processing package Titanium 2 pcs.

Titanium matrix housing

incl. PEEK mounting insert black Retention inserts white, yellow, green Mounting collar silicone

2010.611 Processing package PEEK 2 pcs.

PEEK matrix housing

2010.710 Retention insert red 4 pcs.

PEEK, pull-off weight extra-light

2010.711 Retention insert white 4 pcs.

PEEK, pull-off weight light

2010.712 Retention insert yellow 4 pcs.

PEEK, pull-off weight medium

2010.713 Retention insert green 4 pcs.

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WP

TISSUE LEVEL SURGICAL

TL WP IMPLANT Ø 4.8 mm

Cover screw sterilized incl.

Wide Platform Ø 6.5 mm · Height Polished Neck 1.8 mm

93727 Ø 4.8 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

93729 Ø 4.8 mm L 12.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

38136 Ø 3.5 mm, L 41 mm

38151 Ø 4.2 mm, L 33 mm

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TISSUE LEVEL SURGICAL WP

93738 Ø 4.2 mm, L 25 mm 95266 Ø 4.8 mm, L 33 mm 93730 small 61314 Ø 4.8 mm, L 42 mm Healing abutments 93731 GH 2.0 mm 93732 GH 3.0 mm 93733 GH 4.5 mm

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TISSUE LEVEL PROSTHETICS WP

STANDARD

Impression 93734 Model 93735 63978 Single crown 64551 Bridge 64553 93736 cementable 93739 93737 93720 screwed 93721 Bridge/Bar 93722 Crown 31160

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93734 TL WP Impression cap with integral guide screw (open tray)

93739 TL WP Abutment angled, 15° A

H 5.5 mm, cementable

93735 TL WP Implant analog 93737 TL WP Abutment angled, 15° B

H 5.5 mm, cementable 93720 TL WP Abutment H 1.5 mm, screwed 93721 TL WP Plastic coping bridge/bar for 93720 93736 TL WP Abutment H 5.5 mm, cementable 93722 TL WP Plastic coping crown for 93720 31160 TL RP/WP Occlusal screw for 31164 and 93720

TISSUE LEVEL PROSTHETICS WP

ABUTMENTS ANGLED VERSIONS

A

+

B

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BONE LEVEL SUMMAR

Y

* Cover screw sterilized 22014 incl.

** Cover screw sterilized 22099 incl.

OKTAGON

®

_{BONE LEVEL IMPLANTS}

BONE LEVEL · BL

NC Ø 3.3 mm Ø 3.6 mm Ø 4.8 mm L 8.0 mm 22009* Closur e-scr ews Healing abutments GH 2.0 mm 22017 22020 L 10.0 mm 22010* GH 0.0 mm 22013 GH 3.5 mm 22018 22021 L 12.0 mm 22011* GH 0.5 mm 22014 GH 5.0 mm 22019 22022 L 14.0 mm 22012* RC Ø 4.1 mm Ø 5.0 mm Ø 6.5 mm Ø 7.0 mm L 8.0 mm 22001** Closur e-scr ews Healing abutments GH 2.0 mm 22090 22093 L 10.0 mm 22002** GH 0.0 mm 22098 GH 4.0 mm 22091 22094 ₂₂₁₂₃ L 12.0 mm 22003** GH 0.5 mm 22099 GH 6.0 mm 22092 22095 L 14.0 mm 22004** RC Ø 4.8 mm Ø 5.0 mm Ø 6.5 mm Ø 7.0 mm L 8.0 mm 22005** Closur e-scr ews Healing abutments GH 2.0 mm 22090 22093 L 10.0 mm 22006** GH 0.0 mm 22098 GH 4.0 mm 22091 22094 22123 L 12.0 mm 22007** GH 0.5 mm 22099 GH 6.0 mm 22092 22095 L 14.0 mm 22008**

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RESTORA

TION OPTIONS

* Insertion in the molar region is not recommended. Applies to all BL NC implants Ø 3.3 mm.

(36)

INDICATIONS BONE LEVEL

NARROW CONNECT (NC)

Implant-Ø _{3.3 mm}

Lengths mm 8 10 12 14

BL NC x x x x

Ø For bone level restorations in combination with subgingival and transgingival healing.

Ø 3.3 mm Ø Bone Level Implants are an alternative option for cases with a minimum jaw

width of 6.0 mm and a mesiodistal gap of 5.0 mm between adjacent teeth.

The BONE LEVEL NC implants Ø 3.3 mm are only to be restored in combination with the

color-coded (yellow) NC abutments. Except ALLIGATOR and LOCATOR® _Abutments.

SPECIFICATIONS BL NC Implant-Ø mm 3.3 Platform-Ø mm 3.3

¦

|

¦

|

¦

|

¦

|

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|

Pitch mm 0.8 Outer-Ø mm 3.3 Inner-Ø mm 2.8 Note

The Countersink is used for a conical preparation of the implant site.

BONE LEVEL INDICA

(37)

BL RC x x x x x x x x

Ø For bone level restorations in combination with subgingival and transgingival healing.

Ø 4.1 mm Ø Bone Level Implants are an alternative option for cases with a minimum jaw

width of 6.0 mm and a mesiodistal gap of 6.0 mm between adjacent teeth.

Ø 4.8 mm Ø Bone Level Implants are for cases with a minimum jaw width of 7.0 mm and a

mesiodistal gap of 7.0 mm between adjacent teeth.

The BONE LEVEL NC implants Ø 3.3 mm are only to be restored in combination with the

color-coded (magenta) NC abutments. Except ALLIGATOR and LOCATOR® _Abutments.

SPECIFICATIONS BL RC Implant-Ø mm 4.1 4.8 Platform-Ø mm 4.1 4.8

¦

|

¦

|

¦

|

¦

|

¦

|

Pitch mm 0.8 0.8 Outer-Ø mm 4.1 4.8 Inner-Ø mm 3.5 4.2

BONE LEVEL INDICA

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BONE LEVEL SURGICAL

NC

BONE LEVEL SURGICAL

BL NC IMPLANT Ø 3.3 mm

22009 Ø 3.3 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

22011 Ø 3.3 mm L 12.0 mm

22012 Ø 3.3 mm L 14.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

(39)

BONE LEVEL SURGICAL

NC

22136 Ø 3.3 mm, L 26 mm 22138 Ø 3.3 mm, L 23 mm 22013 GH 0.0 mm 22137 Ø 3.3 mm, L 35 mm 22014 GH 0.5 mm Healing abutments Ø 3.6 mm 22017 GH 2.0 mm 22018 GH 3.5 mm 22019 GH 5.0 mm Healing abutments Ø 4.8 mm 22020 GH 2.0 mm 22021 GH 3.5 mm 22022 GH 5.0 mm

(40)

BONE LEVEL PROSTHETICS NC

STANDARD

Impression 22015 Model 22016 63978 Single crown 64551 Bridge 64553 22025 22026 22027

}

22035 Bridge 22028 22034 Crown cementable 22029 22023 22024 22030 22043

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BONE LEVEL PROSTHETICS NC

22015 BL NC Impression cap, Ø 4.0 mm

with integral guide screw (open tray)

22027 BL NC Abutment, 0°, Ø 3.5 mm

L 5.5 mm, GH 1.0 mm, cementable basic screw 22043 incl.

22016 BL NC Implant analog 22028 BL NC Abutment, 0°, Ø 3.5 mm

22035 BL NC Burn-out plastic coping

Ø 3.5 mm, for Bridge

22034 BL NC Burn-out plastic coping

Ø 3.5 mm, for Crown

22043 BL NC Basic screw L 7.85 mm 22030 BL NC Basic screw L 7.85 mm 22032 BL NC Basic screw for CAD/CAM

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BONE LEVEL PROSTHETICS NC

ALLIGATOR

2010.601 Impression 22015 Model 22016 2010.611 63978 64551 2010.701 64553 2010.702 Hybrid 2010.731 2010.710 2010.711 Impression 2010.722 2010.712 Model 2010.721 2010.713 2010.714 2010.715 2010.725 2010.731 22036 2010.741 0° 22037 22038 2010.751 22039 75836 2010.703 Hybrid 2010.723 2010.724 63978 64551 2010.101 64553 15° 22041 22042

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22038 BL NC ALLIGATOR Abutment GH 4.0 mm

22131 BL NC/RC ALLIGATOR basic screw

for 22041/22042/22129/22130 22039 BL NC ALLIGATOR Abutment GH 5.0 mm 64551 OKTAGON®_Screwdriver one-piece, L 24 mm 75836 TL/BL ALLIGATOR Attachment driver, L 15 mm

NOVALOC

_™

grey

black

Aluminium

2010.722 Forming/fi xing matrix, red 4 pcs.

PEEK

2010.101 Equipment Box

with 3 tools

2010.731, 2010.741, 2010.751 (excluding consumables)

PEEK matrix housing

PEEK, pull-off weight strong

(44)

BONE LEVEL SURGICAL RC

BONE LEVEL SURGICAL

BL RC IMPLANT Ø 4.1 mm

22001 Ø 4.1 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

22003 Ø 4.1 mm L 12.0 mm

22004 Ø 4.1 mm L 14.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

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BONE LEVEL SURGICAL RC

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BONE LEVEL SURGICAL

RC

BONE LEVEL SURGICAL

BL RC IMPLANT Ø 4.8 mm

22005 Ø 4.8 mm L 8.0 mm

79575

Ø 2.0/3.0 mm

31061 Ø 2.2 mm, L 33 mm

22007 Ø 4.8 mm L 12.0 mm

22008 Ø 4.8 mm L 14.0 mm

64557

Ø 2.0 mm, L 25 mm

38120 Ø 2.2 mm, L 33 mm

38121 Ø 2.2 mm, L 41 mm

38149 Ø 2.8 mm, L 33 mm

38148 Ø 2.8 mm, L 41 mm

64556

Ø 3.0 mm, L 25 mm

38135 Ø 3.5 mm, L 33 mm

38136 Ø 3.5 mm, L 41 mm

38151 Ø 4.2 mm, L 33 mm

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BONE LEVEL SURGICAL

RC

(48)

BONE LEVEL PROSTHETICS RC

STANDARD

22096 Impression 22088 Model ₂₂₀₈₉ 22097 63978

Single crown temporary

64551 22121 Bridge 64553 22103 22105 22106

}

22116 Bridge 22117 Crown 22107 cementable 22108 22109

}

22118 Bridge 22119 Crown 22110 22115 22120

BONE LEVEL PROSTHETICS RC

OKTAGON

®

_{BONE LEVEL ABUTMENTS}

• The conical joint between abutment and implant provides a safe support and power transmission of the abutment to the implant and ensures the tightness of the joint.

• The deep fi xture of the screw in the implant leads to a functional stress distribution and due to this provides a high breaking strength and endurance.

• The endurance of the joint is proved according to DIN EN ISO 14801 [Data on fi le].

NOTE

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22096 BL RC Impression cap, Ø 4.5 mm with integral guide screw (open tray)

22097 BL RC Implant analog

22088 BL RC Impression cap, Ø 5.0 mm

22121 BL RC Temporary coping

0°, Ø 7.0 mm, customizable basic screw 22122 incl.

22089 BL RC Impression cap, Ø 6.5 mm

22122 BL RC basic screw

also suiting for CAD/CAM

22103 BL RC Abutment, 18°, Ø 5.0 mm

L 8.0 mm, GH 1.5 mm, cementable incl. basic screw 22120

22118 BL RC Burn-out plastic coping

22120 BL RC basic screw, L 7.5 mm

for cementablees Abutment

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BONE LEVEL PROSTHETICS RC

ALLIGATOR

22096 2010.601 22088 Impression 22089 Model 22097 2010.611 63978 64551 2010.701 64553 2010.702 Hybrid 2010.731 2010.710 2010.711 Impression 2010.722 2010.712 Model 2010.721 2010.713 2010.714 2010.715 2010.725 22124 22125 0° 22126 2010.731 22127 22128 2010.741 75836 2010.751 Hybrid 2010.703 63978 2010.723 64551 2010.724 64553 2010.101 15° 22129 22130

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22126 BL RC ALLIGATOR Abutment GH 3.0 mm

22131 BL NC/RC ALLIGATOR Basic screw

for 22041/22042/22129/22130 22127 BL RC ALLIGATOR Abutment GH 4.0 mm 64551 OKTAGON®_Screwdriver one-piece, L 24 mm 22128 BL RC ALLIGATOR Abutment GH 5.0 mm 75836 TL/BL ALLIGATOR attachment driver, L 15 mm

NOVALOC

_™

BONE LEVEL PROSTHETICS NC

grey

black

Aluminium

2010.722 Forming / fi xing matrix, red 4 pcs.

PEEK

2010.101 Equipment Box

with 3 tools

2010.731, 2010.741, 2010.751 (excluding consumables)

PEEK matrix housing

(52)

OKTAGON

®

_{INSTRUMENTS AND TOOLS}

PARALLEL PINS

RP/TD/WP/BL

Ø 2.0/3.0 mm 79575

DEPTH GAUGES

RP/TD/WP/BL

Ø 2.0 mm Ø 3.0 mm L 25 mm 64557 64556

DRILL TOOLS

RP/TD/WP/BL

Pilot drill Ø 1.54 mm 11594 Drill extension L 27 mm 11592

ADAPTER

RP/TD/WP/BL

31056 64558 11607 31057 17372 31052

SCREWDRIVER

RP/TD/WP/BL

63978 64551 64553

EMERGENCY 24h TOOLS

RP/TD/WP

BL NC

BL RC

64548 64547 64550 64549 INSTRUMENTS

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INSTRUMENTS

X-Ray reference spheres

87434

COMPONENTS

RP/TD/WP/BL

Surgical kit 82895* 82894*

DRILL-STOP CONTROL

RP/TD/WP/BL

W 80 x H 37 x D 25 mm 38170 187RF018 TL/BL Pilot drill Ø 1.8 mm L 12.0 mm 38160 TDS15020 TL/BL Twist drill Ø 2.0 mm L 33.5 mm 38161 TDS15028 TL/BL Twist drill Ø 2.8 mm L 33.5 mm 38162 TDS15035 TL/BL Twist drill Ø 3.5 mm L 33.5 mm 38163 TDS15042 TL/BL Twist drill Ø 4.2 mm L 33.5 mm 38164 CL032 TL/BL Drill Sleeve 14.0 mm 38165 CL034 TL/BL Drill Sleeve 12.0 mm

(54)

INSTRUMENTS

Round bur Twist drill Twist drill Twist drill

BL

Tap

(max. 800 min−1₎ (max. 600 min−1) (max. 500 min−1) (max. 400 min−1) _{(max. 15 min}−1₎

Ø 2.2 mm Ø 2.8 mm Ø 3.5 mm Ø 4.2 mm Ø 3.3 mm

31061 38149 38135 38151 22138

Twist drill Tap Tap Tap Parallel-Pin (max. 800 min−1₎ _{(max. 15 min}−1₎ _{(max. 15 min}−1₎ _{(max. 15 min}−1₎

Ø 2.2 mm Ø 3.3 mm Ø 4.1 mm Ø 4.8 mm Ø 2.0/3.0 mm

38120 95267 95265 95266 79575

Pilot drill Tap Countersink Countersink (max. 800 min−1₎ _{(max. 15 min}−1₎ _{(max. 300 min}−1₎ _{(max. 300 min}−1₎

Ø 1.54 mm Ø 3.3 mm Ø 3.5 mm Ø 4.2 mm

11594 72268 93740 93738

Drill Extension FREE FREE FREE 11592

(55)

TISSUE LEVEL Ø 3.3 mm TISSUE LEVEL Ø 4.1 mm

TISSUE LEVEL Ø 4.8 mm

BONE LEVEL

INSTRUMENTS & TOOLS

Countersink Tap Countersink Tap Countersink (max. 400 min−1₎ _{(max. 15 min}−1₎ _{(max. 300 min}−1₎ _{(max. 15 min}−1₎ _{(max. 300 min}−1₎

Ø 3.3 mm Ø 4.1 mm Ø 4.1 mm Ø 4.8 mm Ø 4.8 mm

22136 95264 22111 95269 22114

Parallel-Pin Depth Gauge Depth Gauge Adapter Screwdriver

-

--

-Ø 2.0/3.0 mm Ø 2.0 mm Ø 3.0 mm

79575 64557 64556 17372 64551

Holding Key FREE

64553 64553

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PILOT DRILL TWIST DRILL

Pilot drill Twist drill Twist drill Twist drill Twist drill Tap

(max. 800 min−1₎ _{(max. 800 min}−1₎ (max. 600 min−1) (max. 500 min−1) (max. 400 min−1) _{(max. 15 min}−1₎

Ø 1.54 mm Ø 2.2 mm Ø 2.8 mm Ø 3.5 mm Ø 4.2 mm Ø 3.3 mm

11594 38120 38149 38135 38151 95267

Round bur Twist drill Twist drill Twist drill Twist drill Tap

(max. 800 min−1₎ _{(max. 800 min}−1₎ _{(max. 600 min}−1₎ _{(max. 500 min}−1₎ _{(max. 400 min}−1₎ _{(max. 15 min}−1₎

Ø 2.2 mm Ø 2.2 mm Ø 2.8 mm Ø 3.5 mm Ø 4.2 mm Ø 3.3 mm

31061 38121 38148 38136 38152 72268

Parallel pins Tap Countersink Countersink Tap

(max. 15 min−1₎ _{(max. 400 min}−1₎ _{(max. 400 min}−1₎ _{(max. 15 min}−1₎

Ø 2.0/3.0 mm Ø 3.3 mm Ø 3.3 mm Ø 3.3 mm Ø 4.1 mm

79575 22138 22136 22137 95264

FREE Screwdriver Screwdriver Screwdriver Adapter 63978 64551 64553 31052

FREE _{Holding key}

64563 FREE

Torque ratchet

FREE 89048

INSTRUMENTS

OKTAGON

SURGICAL KIT

64563

(57)

TAPS DEPTH GAUGE WP TD

Tap Tap Depth gauges Depth gauges Countersink Countersink (max. 15 min−1₎ _{(max. 15 min}−1₎ _- _- _{(max. 300 min}−1₎ _{(max. 300 min}−1₎

Ø 4.1 mm Ø 4.8 mm Ø 2.2/2.8 mm Ø 3.5 mm Ø 4.2 mm Ø 3.5 mm

95265 95266 64560 64561 93738 93740

Tap Tap Depth gauges FREE FREE FREE (max. 15 min−1₎ _{(max. 15 min}−1₎

-Ø 4.1 mm Ø 4.8 mm Ø 4.2 mm

31088 61314 64562

Countersink Countersink Tap Countersink Countersink Drill extension (max. 300 min−1₎ _{(max. 300 min}−1₎ _{(max. 15 min}−1₎ _{(max. 300 min}−1₎ _{(max. 300 min}−1₎

Ø 4.1 mm Ø 4.1 mm Ø 4.8 mm Ø 4.8 mm Ø 4.8 mm 22111 22113 95269 22114 22112 11592 TISSUE LEVEL Ø 3.3 mm TISSUE LEVEL Ø 4.1 mm TISSUE LEVEL Ø 4.8 mm BONE LEVEL

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Vail Mountain Marriott

January 28

th

_{– February 1}

st

_{, 2015}

Vail, Colorado, USA

5 th

_{ANNUAL HIGH ALTITUDE}

COMPREHENSIVE IMPLANT SYMPOSIUM

Pre-Registration

Going on NOW!

MEISINGER

R

PRESENTS

P

CALL T

ODAY

+49 2131 201 2-441

SAVE

_THE

DATE

(Formally High Altitude Bone Management

®

_{Winter Camp)}

Speakers:

Dr. Dwayne Karateew Dr. Mitra Sadrameli Dr. Scott Ganz Dr. Robert Gellin Dr. Robert Miller Dr. Michael Block Dr. Michael Pikos Dr. Istvan Urban Dr. Sascha Jovanovic Dr. Daniel Cullum Dr. Brian Butler Dr. John Russo

Hager & Meisinger GmbH

Hansemannstr. 10 • 41468 Neuss • Germany Fax: +49 2131 2012-222

(59)

COMPREHENSIVE IMPLANT SYMPOSIUM

re-Registration

Going on NOW!

(60)

INFORMA

TION

TORQUE VALUES AND SPEEDS

Diameter Torque Speed Tools

Implants Ø 3.3 mm Ø 4.1 mm Ø 4.8 mm max. 35 Ncm max. 35 Ncm max. 35 Ncm max. 15 min-1 max. 15 min-1 max. 15 min-1 Handpiece adapter Finger wheel Torque ratchet Pilot drills Ø 1.54 mm Ø 1.8 mm -max. 600 min-1

max. 600 min-1 Handpiece adapter

Round burs Ø 2.2 mm - max. 800 min-1 _{Handpiece adapter}

Twist drills Ø 2.0 mm Ø 2.2 mm Ø 2.8 mm Ø 3.5 mm Ø 4.2 mm -max. 800 min-1 max. 800 min-1 max. 600 min-1 max. 500 min-1 max. 400 min-1 Handpiece adapter Countersinks Ø 2.8 mm Ø 3.3 mm Ø 3.5 mm Ø 4.2 mm -max. 300 min-1 max. 300 min-1 max. 300 min-1 max. 300 min-1 Handpiece adapter Taps Ø 3.3 mm Ø 4.1 mm Ø 4.8 mm -max. 15 min-1 max. 15 min-1 max. 15 min-1 Handpiece adapter Finger wheel Torque ratchet Cover screws -hand screwed - Screwdriver Torque ratchet Healing abutments

-Occlusal screw - max. 15 Ncm

Abutments - max. 35 Ncm

-Screwdriver

Ball Attachments - max. 35 Ncm

Solid abutment driver Screwdriver

ALLIGATOR/LOCATOR® _- _{max. 35 Ncm}

(61)

Ball attachments Solid abutments Pure titan grade 5

(3.7165 Medical Grade) according ASTM F 136 (2013)

Basic screws for Abutments ALLIGATORS incl. screw Occlusal screws

Impression caps incl. screw Temporary copings

Stainless steel (1.4197)

according ASTM F 899b (2012)

Round bur, Twist drills, Profi l drills Taps Countersinks Emergency 24h Tools Handpiece adapter Screwdriver Adapter Parallel Pins Depth gauges Holding key Handpiece Stainless steel (1.4305) according DIN EN 10088-3 (2012)

X-Ray reference spheres Torque ratchet

EPDM

according FDA CFR Title 21 (2013)

O-Rings

70 shore red light

80 shore blue medium

90 shore black strong

Polyoxymethylen (POM)

according DIN EN ISO 13504 (2012)

OKTAGON®_{plastic copings, OKTAGON}®_{impression caps,}

interior trim of adapter ball attachments Polyetheretherketon 100 % (PEEK)

Mouth-resistant plastic

Temporary copings

Polysulfon (PSU)

Multi function abutments

Novaloc

™

Polyetheretherketon 100 % (PEEK) Mouth-resistant plastic

according ISO 15309 (2013)

Plastic parts

Pure titan grade 4 (3.7065) according ASTM F 67 (2013)

(62)

INFORMA

TION

MANUFACTURER INFORMATION

DENTAL RATIO products for dental implantology are of high quality and manufactured by the traditional German company Hager & Meisinger, a guarantee for high-grade medical products over the past 125 years.

Hager & Meisinger assure the quality of their products by means of unlimited, uninterrupted monitoring of all production stages and the high quality of materials used as well as continuous monitoring of storage conditions.

Certifi ed according to: • ISO 9001

• ISO 13485

• Medizinprodukterichtlinie 93/42/EWG

(63)

COMPANY AND PROCESS EVALUATION

• Regular examination of product fi les by the notifi ed body

• Total recertifi cation of the QM system every 3 years by the notifi ed body • Monitoring at least once per year by the notifi ed body

• More than 10 customer audits per year (sometimes several days) • Annual internal audits in all relevant parts of the company

(64)

INFORMA

TION

QUALITY ASSURANCE THROUGHOUT

THE MANUFACTURING PROCESS

COURSE OF ACTION

• Unlimited, uninterrupted traceability of all production stages • Invariably monitored production (no unmanned production) • Continuous monitoring of storage conditions to ensure sterility

VALIDATION

• All relevant processes (including cleaning) are validated • Validated packaging (in cleanroom) and sterilisation • Regular revalidation of all processes

MEASUREMENT AND TESTING EQUIPMENT

• State-of-the-art, calibrated measuring and testing equipment used (partly computer-aided) • Continuous monitoring of all test equipment within the certifi ed QM system

TESTS

IN-PROCESS

• Bioburden test for determining the microbial count • Incoming goods test on the materials

• Surface analysis with a scanning electron microscope to test the surface topography (macro/micro cluster)

• Documented fi nal check including a 100% test of the most important functional features • Documented X-ray spectral analysis of all manufacturing orders for production residues

REGULAR

• Endotoxine test during cleaning validation • Particle test during cleaning validation

• Cytotoxicity tests on packaged and sterilised products to confi rm biocompatibility Use of accredited partner companies for external laboratory tests

FURTHER TECHNICAL DETAILS

ABUTMENTS

• Passivated surface to reduce the risk of cold welding

CONNECTOR

• All screw connectors standardised (ISO 10664)

• Torque is transferred fi rmly and adequate clamping is achieved between the screw and screwdriver

IMPLANT SYSTEMS

• Matched tolerance concept between the individual components (e.g. the pitch of the implant corres-ponds to that of the tap)

• A sterile cover screw is included right in the sterile package • Primary and secondary packaging ensure sterility

(65)

(66)

INFORMA

TION

GUARANTEE

The guarantee relates to the OKTAGON®_{and HEXATEC}®_{implant systems of DRS} International GmbH, hereinafter referred to as «DRS products and components». In addition to the statutory seller’s warranties we provide – at the discretion of the authorised persons from this guarantee – a guarantee as follows: 1 SCOPE OF GUARANTEE

In accordance with our guarantee promise DRS guarantees treating dentists, who after 01.01.2014 fi tted original DRS products and components in their pa-tients under the following requirements and conditions, to replace these DRS products and components if the fi xation fails. This includes free delivery of the relevant DRS product and DRS components as well as compensation of the resulting additional treatment costs for replacement. The guarantee only co-vers the normal wear of DRS implants and abutments with a lifetime guarantee excluding instruments. It is a requirement of the guarantee that the patient did not have any contraindications specifi ed in the product description before, du-ring or after implant placement. This obligation applies only for DRS products, which have been sold in Germany by DRS and inserted in Germany. The basis of the guarantee is always the individual guarantee certifi cate given by DRS with the delivery of a DRS product. The obligation is only for the benefi t of a treating doctor/dentist. Third parties, in particular patients or intermediate sup-pliers cannot derive any rights from this guarantee. The assignment of claims from the guarantee declaration is excluded. This guarantee programme is valid in the Federal Republic of Germany.

2 GUARANTEE CONDITIONS AND EXCLUSIONS

DRS undertakes to replace only if the fi xation fails within lifetime guarantee, even though the following essential conditions have been fulfi lled by the treating dentist or doctor and/or patient:

• The patient must be carefully selected by the treating dentist and/or doctor, informed about the risks connected with the treatment and the obligations of the patient and asked to cooperate.

• The indications/contraindication must be carefully observed and documen-ted. [More details are available in the respective product descriptions.] • At the time of treatment the available instructions from DRS and recognised

dental medical procedures must be observed and used accordingly befo-re, during and after implant placement. The attending doctor is additionally responsible to regularly inform himself about the current status of the DRS products and components and their proper use.

• Continual good oral hygiene by the patient and checks at regular intervals must be ensured and documented.

• The product that is the subject of the claim must be returned in a sterilised state for the purpose of identifi cation. A completed guarantee form, the ori-ginal guarantee certifi cate and the required additional documents for fulfi lling the conditions of the guarantee must be submitted together with the product. • The guarantee does not apply: if DRS products have been modifi ed or if DRS

products have been used in combination with products that did not originate from DRS; for special designs or specially fabricated or modifi ed products; if failure of an implant is triggered or induced by an accident, trauma or other damages caused by the patient or a third party; and in case the disadvantage bases on the fact the attending doctor does not have provable knowledge of implantation technology or does not have according qualifi cation in this special fi eld.

3 PROCEDURE FOR GUARANTEE CLAIMS

If you think you meet the requirements for making a claim under guarantee, within the framework of the guarantee procedure you must submit a comple-ted and signed guarantee form (including the required attachments therein) together with the original of the guarantee certifi cate to DRS within 1 year of becoming aware of the failure of the DRS products and/or components. All components must be returned sterilised.

4 TERMINATION

DRS can change or end this warranty program in relation with any product or in relation with the entitlement of a specifi c treating Dentist or Doctor at any time. Already existing guaranties remain unchanged in their coverage as on purchasing date.

5 OTHER

By participating in this guarantee programme and the purchase of products from DRS in connection with it, the treating dentist and/or doctor accepts the conditions defi ned herein.

6 VALIDATION

These warranty terms are valid beginning from 01.06.2014 for all DRS products and/or components used after 01.01.2014. In case at the time of purchasing DRS products and/or components the then valid warranty terms were covering a larger scope of warranty terms as the actual valid terms, then these terms will apply.

Issue August 2014

GENERAL TERMS AND CONDITIONS

1. GENERAL/SCOPE

1.1. Our terms and conditions of delivery and payment apply for all business relationships with our customers and customers accept them as binding for them with placement of an order.

1.2. Conditions that deviate from the following and/or legal provisions – in particular in the conditions of purchase of the customer – are only bin-ding for us, if they have been confi rmed in writing. This also applies for conditions, which are not stipulated in our terms and conditions for delivery and payment. The unconditional delivery of goods or receipt of payment does not mean any acceptance of deviating provisions by us. 1.3. All agreements, which are reached between us and the customer for the

purpose of fulfi lling a contract, are laid down in writing in the contract and in these applicable terms and conditions. Changes, additions or cancellation of a contract or these terms and conditions are only effecti-ve with our written confi rmation.

2. OFFERS/OFFER DOCUMENTATION

2.1. Our offers are non-binding, if no other agreement has been made. 2.2. Illustrations, drawings, calculations and other product, application or

project related documents remain our property and are subject to copy-right, even if we place them at the customer’s disposal: they may not be reproduced or made accessible to third parties without our express prior written consent.

3. PRICES/TERMS OF PAYMENT

3.1. Unless otherwise agreed, our prices apply “ex-works”. The costs for package, insurance, freight and VAT are not included and will be in-voiced separately. The VAT will be shown separately on the invoice at the statutory rate on the invoice date. If we do not have any written request in advance by the recipient for uninsured delivery, all our shipments will be internationally insured at the expense of the recipient.

3.2. With customer-specifi c production we are entitled to an over or under delivery of 10% in relation to the order quantity and to invoice accor-dingly.

3.3. Unless otherwise agreed, the purchase price is net (without deductions) payable within 30 days from the date of the invoice. Deduction of a dis-count requires special written agreement.

3.4. Should the customer be in default of payment, we are entitled to charge default interest at 8% over the current valid base interest rate. We are entitled to charge reminder fees of 30.00 to 60.00 EUR for each reminder depending on the reminder stage.

3.5. If, after conclusion of the contract, a signifi cant deterioration of the customer’s fi nancial circumstances is recognised which will endanger our claim for payment, provided there is an obligation for advance per-formance we are entitled to withhold our perper-formance up and until pay-ment is effected or security is provided to us for our paypay-ment claim. If, after a reasonable deadline set by us, the customer is neither willing to perform concurrently nor provide security we will be entitled to rescind the contract.

3.6. The customer shall only be entitled to offsetting rights, if they have been established by us as existing and due or enforced by law. The customer is only entitled to right of retention in so far as the counterclaim is based on the same contractual relationship.

4. DELIVERY, DELIVERY TIMES, PART DELIVERIES

4.1. Fulfi llment with our delivery obligations shall depend on punctual due fulfi lment of the obligations of the customer, in particular compliance with the agreed terms and conditions of payment. The right to raise an objection to a non-fulfi lled contract is reserved.

4.2. The delivery times agreed in writing begin on the day of our confi rmation but not before clarifi cation of all technical and commercial details as well as presentation of any authorisations required. Any modifi cations requested by the customer regarding the delivery of the contractual ob-ject within the period of delivery shall interrupt and extend the period of delivery accordingly.

4.3. Occurrence of unforeseen events, force majeure and non-delivery by our supplier for which we are not responsible entitle us to suspend the deli-very for the duration of the disruption and a reasonable restarting period. 4.4. Partial deliveries are permitted to a reasonable extent.