MILLING ABUT-MENT FOR CAD/CAM TYPE I & II.FOR CUSTOMIZED ABUTMENTS.Prosthetic Procedure

2 © Thommen Medical

1. At a glance

Component Material

Milling abutment for CAD/CAM type I Pure titanium grade 4 according ASTM F 67/ISO 5832-2

Milling holder for CAD/CAM type I Stainless steel

Milling abutment for CAD/CAM type II Pure titanium grade 4 according ASTM F 67/ISO 5832-2

Abutment screw Titanium alloy

INDICATIONS FOR USE

Thommen Milling abutments for CAD/CAM are intended to be used in conjunc-tion with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

RESTRICTIONS FOR USE

Precautions, possible complications, limitations see page 6.

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CLINICAL USE

Milling abutments from Thommen Medical for CAD/CAM are manufactured with the same precise connection geometry as all Thommen Medical pro-ducts.

The milling abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM system to fabricate a customized abut-ment made of titanium.

Final abutments are to be sterilized prior to intraoral placement. Each patient specific abutment is individually prescribed by the clinician.

Before inserting and attaching of the prosthetic components, the implant shoulder and inner configuration must be free of contaminants and over-hanging soft tissue.

Always use a new abutment screw when inserting the abutment into the patient’s mouth. Secure the abutment against aspiration during insertion. Tighten the abutment screw with the Thommen MONO screwdrivers (4 lobe) and the associated MONO torque ratchet to the specific torque value.· 15 Ncm for PF B 3.5 mm· 25 Ncm for PF B 4.0–6.0 mm

You can find an overview of all torques values for the attachment of Thommen Abutments online at: www.ifu-tm.com/THM61122.

IMPRESSION TAKING

A prosthetic restoration with Milling abutments for CAD/CAM requires an impression to be taken at implant level. Thommen scan abutments are used for digital impression taking and can be used intraorally or for scanning from the master model.

For more information about digital impression taking with scan abutment, please refer to www.ifu-tm.com/THM61143.

For more information about impression taking with impression coping, please refer to www.ifu-tm.com/THM61127.

MASTER CAST FABRICATION

Implant analogs are available for milling abutments for CAD/CAM. Standard procedures apply and do not require specific instruction.

2. Application and handling

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CAD IN THE LABORATORY

Take note of the minimum machining boundaries (parameters). The parame-ters are incorporated in the Thommen Medical library of the “Abutment De-signer – 3shape Dental System” software. Contact the technical Service De-partment of Thommen Medical if libraries are not present in the software used.

Parameters:Maximal angulation 20°Minimal wall thickness 0.4 mm Maximum gingival height 7.0 mmMinimum abutment height 4.5 mm

CAM FABRICATION IN MILLING CENTRES

The milling abutment is supplied with an abutment screw. The packed abut-ment screw is intended for the final restoration of the patient and must be for-warded to customers together with individualized milling abutment (traceabi-lity). The packed abutment screw provided in the package is not to be used to fix the abutment to the milling holder and must not be used in the milling pro-cess. Individually packed abutment screws are available for the milling proce-dure.

Take note of the specified torque value when mounting the milling abutment for CAD/CAM type I onto the milling holder for CAD/CAM type I. Refer to the follow-ing torque value specifications:· 15 Ncm for PF B 3.5 mm· 25 Ncm for PF B 4.0–6.0 mm

The milling abutment for CAD/CAM type II is processed using an original Medentika® PreFace® abutment holder in a compatible milling system. The PreFace® abutment holder must be ordered directly from the milling ma-chine manufacturer. The instructions for use for the Medentika® PreFace® abutment holder can be provided by the milling machine manufacturer.

For information on which milling machines the milling abutment for CAD/CAM type II is compatible, visit: www.thommenmedical.com.

Minimummachiningboundaries

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CLEANING, DISINFECTION AND STERILISATION

Thommen abutments and components are supplied in non-sterile condition. Abutments and their components must be cleaned, disinfected and sterilized before and after contact with patient’s mouth.

Sterilisation parameters A fractionised vacuum procedure with at least 3 vacuum steps (with adequate product drying).

Valid for wrapped instruments and utensils by using an FDA cleared sterilisa-tion pouch:

Temperature Sterilisation time Drying time

132°C/270 °F 4 minutes 20 minutes

6 © Thommen Medical

3. General notes

THOMMEN IMPLANT SYSTEM

Manufacturer: Thommen Medical AG Neckarsulmstrasse 28 2540 Grenchen, Switzerland www.thommenmedical.com

Batch code

Use by date

Date of manufacture

Sterilized using irradiation

Sterilized using steam or dry heat

Temperature limitation

Do not re-use

Non-sterile

Caution

Article number

Conformity symbol as specified by EU Directive MDD 93/42/EEC

Consult instructions for use

Do not resterilize

Do not use if package is damaged

Atmospheric pressure limitation

Manufacturer

Keep away from sunlight

May only be sold to and prescribed by physicians (USA)

COLOURED WARNING STICKERApplication has changed - follow the corresponding instruc-tions for use.

New design – the application has not been changed.

PRODUCT INFORMATION The information in this document describes the application of the Thommen Medical implant system. This information is available in electronic form online at: www.ifu-tm.com. For technical advice, the responsible country representative or distributor of Thommen Medical AG is present to answer questions.

COLOR CODE Each implant platform diameter has a color code, which can be found on all implant and abutment packagings, on the impression items and on most diameter-specific instruments.

brown = PF 3.0

Yellow = PF B 3.5 mm

Green = PF B 4.0 mm

Blue = PF B 4.5 mm

Grey = PF B 5.0 mm

Purple = PF B 6.0 mm

AVAILABILITY Not all of the Thommen Medical products mentioned in these instructions for use are available in all countries. The responsible country representative or distri-butor of Thommen Medical AG informs about availability for the country in question.

GENERAL RESTRICTIONS OF USE Restorations with cantilevers to individual implants are not recommended. In-dividual restorations with angled abutments should not be used in regions with high mechanical stress. For implants with a small diameter (PF 3.0 and 3.5), the prosthetic restoration should be constructed in such a way that large bending moment does not occur. The Thommen Medical products may not be used on patients who are known to have allergies to the corresponding materials.

POSSIBLE COMPLICATIONS A stressed loading of the implant or abutment over and above its functional capacity can lead to excessive bone loss or fracture of the implant or restoration. The clinician must supervise the occlusion and functional loading of the prosthetic supraconstruction very carefully.

WARNINGS/PRECAUTIONS All Thommen Medical products that come into effect inside the oral cavity must be protected against aspiration. Thommen Medical products have not been evaluated for safety and compatibility in the MR envi-ronment. Thommen Medical products have not been tested for heating, migration, or image artifact in the MR environ-ment. The safety of Thommen Medical products in the MR environment is unknown. Scanning a patient who has this product may result in patient injury.

RESPONSIBILITY/LIABILITY As a part of an overall scheme, Thommen Medical products may be used only with the ori-ginal components and instruments in accordance with the instructions for use provided by Thommen Medical. The use of non-system parts may compromise the performance of Thommen Medical products and lead to failures. Users must have appropriate knowledge and information about the handling of Thommen Medical products in order to use the products safely and professionally in accordance with the in-structions for use. Thommen Medical products should only be used in accordance with the instructions for use provided by Thommen Medical. The user is obliged to use the Thommen Medical products according to the instructions for use and to check whether the product is suitable for the individual patient situation. The use of Thommen Medical products is the responsibility of the user, as such, beyond the control of Thommen Medical AG. We refuse to accept any responsibi-lity or liability for any damage due to incorrect utilization of the product. Products labeled “Do not re-use” may not be refurbished and/or reused. The refurbishment and/or reuse of these products can affect their function (e.g. fitting and/or cutting properties) as well as their safe use (e.g. risk of infection, disease transmission, fading of the laseror color marks, corrosion). Detailed information about the possible consequences, which may result from negligence to follow this information, can be obtained from the responsible country representative or distributor of Thommen Medical AG. Caution: Federal law (USA) restricts this device to sale by or on the order of a dentist or physician.

GUARANTEE The comprehensive guarantees can be found in the country-specific guarantee leaflets.

TRANSPORT AND STORAGE Please note the specifications on all labels and package leaflets regarding transportation, storage and instructions for use. Products whose packaging is damaged must not be used. Under no circumstances may Thommen Medical products be used beyond the expiry date, as proper functioning or sterility of sterile packaged pro-ducts cannot be guaranteed by the manufacturer anymore.

INSTRUCTIONS FOR USE The following information is not intended as comprehensive for the Thommen Implant Sys-tem. New customers are advised to undergo training by a specialist experienced in the use of this system.

GUARANTEE OF STERILITY Products of the Thommen Implant System supplied in sterile packaging must not be re-steri-lized. If the sterile packaging is damaged during transport or storage, the product may under no circumstances be used. Products that have been opened and have not been immediately used for the intended operation must not be used thereafter. After resterilization, the safety, function and efficacy of the product cannot be guaranteed by the manufacturer. The products intended for single use must never be reprocessed, sterilized or reused and must be dis-posed of safely and properly after use in compliance with all applicable legal and regulatory requirements. Reusable products must be reprocessed according to the instructions for use and, if used on patients, sterilized. They must be checked for their integrity before each use. Any damage (such as scratches, cracks, nicks, notches), as well as bent parts mean that they must not be used any more. The number of reprocessing cycles is limited and must be moni-tored. If the number of cycles is exceeded, proper function and sterility of the product are not guaranteed by the manuf-acturer anymore.

DISPOSAL In the case of cutting products, there is always a risk of injury, therefore the products must be disposed of safely and properly after use, observing all applicable legal and regulatory requirements. Products that have been used on a patient are at risk of infection. After application, they must be disposed of safely and properly in compliance with all applicable legal and regulatory requirements.

COPYRIGHT©/REGISTERED® SPI®, INICELL® and APLIQUIQ® are registered trademarks of Thommen Medical AG. Publi-cation or reproduction is permitted only with the written consent of Thommen Medical AG. LOCATOR® is a registered trademark of Zest Anchors Inc., CA, USA. Novaloc® is a re-gistered trademark of Valoc AG, Möhlin, CH.

VALIDITY © Thommen Medical AG. All rights reserved. This instruction for use replaces all previous editions.

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HEADQUARTERS

Thommen Medical AG Neckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 61 965 90 20Fax +41 61 965 90 21info@thommenmedical.com

SUBSIDIARIES/NATIONAL DISTRIBUTORS

AUSTRALIA/NEW ZEALANDOsteon Medical23/1866 Princess HighwayClayton Victoria 3168 | AustraliaTel. (inside Australia): 1300 411 473Tel. (outside Australia): +61 3 9264 0111info@osteonmedical.comwww.osteonmedical.com

AUSTRIAThommen Medical Austria GmbHMühlgasse 32322 Zwölfaxing | AustriaTel. +43 660 2011953info@thommenmedical.at

BENELUXThommen Medical Benelux B.V. Dierenriem 13738 TP Maartensdijk | NetherlandsTel. +31 30 68 68 468Info.benelux@thommenmedical.nl

CHINA Shanghai Yujing Trading Co., Ltd.Room G | Floor 15th | Plaza JiaFa | No.1Lane 129 | DaTian Road | JingAn DistrictShanghai | ChinaTel. +86 21 62723077Fax +86 21 62175264

FINLAND Vector Laboratories OyEngelinaukio 8 B00150 Helsinki | FinlandTel. +358 400 940 700labs@vektor.fi

FRANCEThommen Medical France10 avenue Gabriel Pierné 77680 Roissy-en-Brie | FranceTel. +33 1 83 64 06 35Fax +33 3 89 33 52 53infos@thommenmedical.fr

GERMANYThommen Medical Deutschland GmbHAm Rathaus 279576 Weil am Rhein | GermanyTel. +49 7621 422 58 30 Fax +49 7621 422 58 41info@thommenmedical.de

HONG KONGShengyuan (Hong Kong) Int. Trade Co. Ltd.Level 13, 68 Yee Wo StreetCauseway Bay | Hong KongTel. +852 530 876 41

ITALYDental Trey S.r.l.Via Partisani, 347016 Fiumana | Predappio (FC) | ItalyTel. +39 0543 929111Fax +39 0543 940659implantologia@dentaltrey.itwww.dentaltrey.it

JAPANJ. Morita Corporation3-33-18, Tarumi-choSuita | Osaka 564-8650 | JapanTel. +81 6 6384 6921Fax +81 6 6384 6746www.morita.com

LITHUANIA/LATVIACERNIKIS MEDICAL PROJECTS, UABSiaures prospektas 5B, KaunasLithuania LT-49191Tel. +370 37 201072Mobile +370 65 771550info@cmp.ltwww.cmp.lt

MIDDLE EASTStar Science International GmbHJupiterstrasse 573015 Bern | SwitzerlandTel. +41 31 941 07 31Fax +41 31 941 07 33star.science@bluewin.ch

NORWAYNovus Dental ASJohannes Bruns gate 50452 Oslo | NorwayTel. +47 951 07 007post@novusdental.nowww.novusdental.no

POLANDC.WITT DENTAL Sp. z o. o.Ul. Granitowa 1087-100 Toruń | NIP 951-15-08-371 | PolandTel. +48 56 623 61 23biuro@cwittdental.plwww.cwittdental.pl

REPUBLIC OF CROATIA Futura Dental d.o.o.Kralja Zvonimira 10810 000 Zagreb | Republic of CroatiaTel. +385 91 6814 860info@futura-dental.hrwww.futura-dental.hr

RUSSIAN FEDERATIONCIS – JSC GeosoftBuild. 14, Ap. 16, 3-ya Mytishchinskaya ul.Moscow, 129626 | Russian FederationTel. +7 495 663 22 11thommenmedical@geosoft.ru

SINGAPOREFONDACO Pte Ltd7 Kaki Bukit Road 1, #03-06Eunos Techno LinkSingapore 415937 | SingaporeTel. +65 6392 2806Fax +65 6392 1296fondaco@fondacosg.com

SOUTH KOREAAPS Advanced Prosthetic Solution201, Kolon Aston505-14 Gasan-dong Geumchoen-guSeoul | South KoreaTel. +82 2 3141 2875Fax +82 2 3141 2877www.apsdd.com

SPAIN/PORTUGALThommen Medical IbéricaC/Los quintos n 103350 Cox (Alicante) | SpainTel. +34 96 536 1020Mobile +34 606 99 78 34info@thommeniberica.com

SWITZERLANDThommen Medical AGNeckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 32 644 30 20Fax +41 32 644 30 25info@thommenmedical.ch

TAIWANEn-Jye International Co., Ltd.No. 18 | Lane 177 | Sec 3 | Chengde Rd.Taipei, 103 TaiwanTel. +886 2 2585 1669Fax +886 2 2585 0892enjye168@gmail.com

TURKEY Bioport Biyolojik Maddeler A.S.Büyükdere cd. Subay evleri 9. Blok D1 EsentepeSisli 34394 Istanbul | TurkeyTel. +90 212 2727577Fax +90 212 2727628info@bioport.com.trwww.bioport.com.tr

USA/CANADAThommen Medical USA L.L.C.1375 Euclid Avenue | Suite 450Cleveland OH 44115 | USATel. +1 866 319 9800 (toll free)Fax +1 216 583 9801info.us@thommenmedical.com orders.us@thommenmedical.com

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