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SPI ® VARIO ABUTMENT 17° SCREW-RETAINED RESTORATIONS. Prostethic procedure
SPI®VARIO ABUTMENT 17°SCREW-RETAINED RESTORATIONS.Prostethic procedure
2 © Thommen Medical
1. At a glance
These instructions apply to all VARIO abutments 17°, including associated VARIO abutment 17° auxiliary parts, as listed in the product catalogue (www.ifu-tm.com/THM31111). There, you will also find directions on the identifying characteristics (geometries, dimensions) of the individual components.
Component Material
VARIO abutment 17° Type A and Type B Pure titanium grade 4
VARIO screw seat HSL/POM (burn-out plastic)
Abutment screw Titanium alloy
Occlusal screw Titanium alloy
INDICATION
Thommen Medical VARIO abutments 17° are to be used in conjunction with Thommen Implant System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
RESTRICTIONS FOR USE
Angled abutments on small diameter implants (PF B 3.5 mm) are not recom-mended for use in the molar region, unless they are splinted to larger diameter implants.
See general restrictions of use (Page 7).
STORAGE
VARIO abutments 17° and burn-out plastic cylinders must be protected from exposure to strong light and heat sources and stored at room temperature.
© Thommen Medical 3
CLINICAL USE
The VARIO abutment 17° is suitable for occlusal screw-retained single or multiple unit restorations where implants have been placed with pro-nounced angulation to the planned prosthetics. The abutments made from CP titanium are available with two different rotational orientations of the cone (Type A (0°) or Type B (30°)) with respect to the hexagon to allow opti-mal alignment of the abutment. The prefabricated gold alloy screw seat for the occlusal screw ensures a precise connection between the finished crown or bridge and abutment.
Before insertion and attachment of the prosthetic components, the implant shoulder and inner configuration must be free of contaminants and overhan-ging soft tissue.
For permanent insertion, it is essential to use new abutment screws. Torque value for the attachment of the VARIO abutments 17°:· 15 Ncm for PF B 3.5 mm· 25 Ncm for PF B 4.0–6.0 mm
Occlusal screw:· 15 Ncm
You can find an overview of all torque values for the attachment of Thommen Abutments online at: www.ifu-tm.com/THM61122.
TAKING AN IMPRESSION
A prosthetic restoration with VARIO abutments 17° requires an impression to be taken at implant level. For more information about impression techniques, please refer to www.ifu-tm.com/THM61127.
MODIFICATION OF THE ABUTMENT
Modification of the VARIO abutments 17° is not permitted (see construction of the final prosthetic restoration).
MASTER CAST FABRICATION
Implant analogs are available in all platform sizes for VARIO abutments 17°. Standard procedures apply and do not require specific instruction.
2. Application and handling
4 © Thommen Medical
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
CONSTRUCTION OF THE FINAL PROSTHETIC RESTORATION
The VARIO abutment 17° is ideally suited for single tooth crowns or small bridges having two implants with minimal divergence and one or two inter-mediary units. The maximum angulation between two implants which can be managed is as follows:· PF B 3.5 mm 6.0°· PF B 4.0 mm 7.0°· PF B 4.5 mm 8.5°· PF B 5.0 mm 11.0°
For bridge restorations with greater implant divergences, it is recommended to use the VARIOmulti abutment system. The minimal assembled height, incl. screw seat, is 7.6 mm measured from the implant shoulder.
The prefabricated, cast-on VARIO screw seat must be used for fabrication of the crown or bridge framework. The plastic burn-out tube may be shortened to the upper edge of the screw seat.
Proper alignment of the abutment allows access to the occlusal screw, which fixes the superstructure to the abutment. In principle, the abutment should have a mesial alignment in the posterior region.
If both abutment types, Type A (0°) or Type B (30°), are fixed to the analog with the same hex, the difference in alignment of the Type B (30°) abutment should be clear. Depending on the available space, implant divergence and internal hex alignment, either the Type A or B abutment will be suitable.
For the framework modeling of the superstructure, the selected abutment is aligned and placed on the analog, then fixed with the corresponding abut-ment screw.
© Thommen Medical 5
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Place the VARIO screw seat on the VARIO abutment 17° and secure it with an occlusal screw.
When constructing the superstructure, always take care to ensure that the occlusal screw is easily accessible with the screwdriver. If a neighboring tooth prevents the the screw seat from being placed in position, the abutment must be unscrewed and realigned on the analog. If access to the occlusal screw is not optimal, due to the new position or persistent tooth obstruction, the abutment with the alternate hex type can be used. The access to the oc-clusal screw with the screwdriver must never be blocked or impeded by neighbouring teeth.
Shorten the plastic cylinder to allow for maximum intercuspation. Avoid occlusal contact of the plastic cylinder with the antagonist tooth.
Maintain a minimum construct height of 7.6 mm.
The VARIO abutment 17° must not be modified in any way as this may affect the precision fit of the screw seat.
Before wax-up, the abutment screw channel must be blocked out with a sui-table material (A) that can be removed without leaving residues. In the case of single crowns, block out the surface of the screw channel such that an antirotation element is generated on the inside of the crown. A corresponding crown or bridge framework (in a bridge situation) is then waxed-up directly onto the abutment with the screw seat.
As the cast-on VARIO screw seat (A) consists of a non-oxidizing gold alloy and does not form an adhesive oxide layer, it cannot be bonded directly onto this alloy. Likewise, if the cast-on alloy is too thin or perforated, this can also lead to bonding problems with the ceramic veneer. The layer of cast-on alloy must have a minimal wall thickness of 0.3 mm. Always follow the general instruc-tions of the alloy manufacturer for the material used.
Material specificationVARIO screw seatNonoxidizing precious metal cast-on alloyMelting interval 1400–1460 °CWAK 25–600 °C 12.8 μm/mkGold 60 %Platinum 24 %Palladium 15 %Iridium 1 %
6 © Thommen Medical
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
Platform �
7.6 mm (minimum construct height)
Hexagontype A
Hexagontype B
Maximum shortable
2.0 mm
30°
A
A
A
A
The waxed-up crown or bridge framework must fit precisely within the abut-ment margin (see red line).
After unscrewing and removing the occlusal screw, carefully remove the prefabricated framework from the abutment. The investment mold and casting processes are carried out according to standard procedures. Coordinate the investment mold with the alloy used (preferably with a high gold content). The procedure for the investment process is also described in the VARIOmulti instructions for use (www.ifu-tm.com/THM61118).
After casting, devest the framework from the investment mold and clean it carefully using standard methods, such as ultrasound, water steam, pickling solution, or fiberglass brush. The cast-on VARIO screw seat (A) must not be sandblasted or reworked under any circumstances, as this may affect the pre-cise fit of the components. In the event of casting errors or damage the work must be redone, particularly if the screw seat is affected. Caution should be exercised when polishing the outer crown margin. Process and finish the construction in the additional working steps according to standard procedures. We recommend the fabrication of a transfer key for the insertion of abutments.
STERILIZATION
Thommen abutments and components are not supplied in a sterile state. Unless directed otherwise, a steam sterilization of the abutment is recom-mended:· Fractionated vacuum procedure with at least 3 vacuum steps,
(with adequate product drying)· A steam sterilizer compliant with EN 13060/ EN 285 and/or ANSI AAMI
ST79· in correspondence with EN ISO 17665 in a validated and product-
specific performance qualification. · Maximum sterilization temperature of 138 °C (280 °F; plus tolerance in
compliance with EN ISO 17665)
Sterilization time, exposure time at sterilization temperature, of at least 4 minutes at 132 °C (270 °F) or (not relevant for USA) 18 minutes at 134 °C (273 °F), prion in-activation. For further instructions on the sterilization of prosthetic components, please refer to the respective valid Thommen Medical processing manuals.
© Thommen Medical 7
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.
HEADQUARTERS
Thommen Medical AG Neckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 61 965 90 20Fax +41 61 965 90 [email protected]
SUBSIDIARIES/NATIONAL DISTRIBUTORS
AUSTRALIA/NEW ZEALANDOsteon Medical23/1866 Princess HighwayClayton Victoria 3168 | AustraliaTel. (inside Australia): 1300 411 473Tel. (outside Australia): +61 3 9264 [email protected]
AUSTRIAThommen Medical Austria GmbHMühlgasse 32322 Zwölfaxing | AustriaTel. +43 660 [email protected]
BENELUXThommen Medical Benelux B.V. Dierenriem 13738 TP Maartensdijk | NetherlandsTel. +31 30 68 68 [email protected]
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 [email protected]
FRANCEThommen Medical France10 avenue Gabriel Pierné 77680 Roissy-en-Brie | FranceTel. +33 1 83 64 06 35Fax +33 3 89 33 52 [email protected]
GERMANYThommen Medical Deutschland GmbHAm Rathaus 279576 Weil am Rhein | GermanyTel. +49 7621 422 58 30 Fax +49 7621 422 58 [email protected]
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 [email protected]
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 [email protected]
MIDDLE EASTStar Science International GmbHJupiterstrasse 573015 Bern | SwitzerlandTel. +41 31 941 07 31Fax +41 31 941 07 [email protected]
NORWAYNovus Dental ASJohannes Bruns gate 50452 Oslo | NorwayTel. +47 951 07 [email protected]
POLANDC.WITT DENTAL Sp. z o. o.Ul. Granitowa 1087-100 Toruń | NIP 951-15-08-371 | PolandTel. +48 56 623 61 [email protected]
REPUBLIC OF CROATIA Futura Dental d.o.o.Kralja Zvonimira 10810 000 Zagreb | Republic of CroatiaTel. +385 91 6814 [email protected]
RUSSIAN FEDERATIONCIS – JSC GeosoftBuild. 14, Ap. 16, 3-ya Mytishchinskaya ul.Moscow, 129626 | Russian FederationTel. +7 495 663 22 [email protected]
SINGAPOREFONDACO Pte Ltd7 Kaki Bukit Road 1, #03-06Eunos Techno LinkSingapore 415937 | SingaporeTel. +65 6392 2806Fax +65 6392 [email protected]
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 [email protected]
SWITZERLANDThommen Medical AGNeckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 32 644 30 20Fax +41 32 644 30 [email protected]
TAIWANEn-Jye International Co., Ltd.No. 18 | Lane 177 | Sec 3 | Chengde Rd.Taipei, 103 TaiwanTel. +886 2 2585 1669Fax +886 2 2585 [email protected]
TURKEY Bioport Biyolojik Maddeler A.S.Büyükdere cd. Subay evleri 9. Blok D1 EsentepeSisli 34394 Istanbul | TurkeyTel. +90 212 2727577Fax +90 212 [email protected]
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 [email protected] [email protected]
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