®
SPI VARIO
ABUTMENT 17°
SCREW-RETAINED
RESTORATIONS.
PROSTETHIC PROCEDURE
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 ⭋ 3.5 mm) are not recommended for use in the molar region, unless they are splinted to larger diameter
implants.
See general restrictions of use (Page 7).
STORAGE
ST
VA
VARIO
abutments 17° and burn-out plastic cylinders must be protected from
exposure to strong light and heat sources and stored at room temperature.
ex
2
© Thommen Medical
2. Application and handling
CLINICAL USE
The VARIO abutment 17° is suitable for occlusal screw-retained single or
multiple unit restorations where implants have been placed with pronounced 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 optimal 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 overhanging 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 ⭋ 3.5 mm
· 25 Ncm for PF ⭋ 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.
© Thommen Medical
3
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 intermediary units. The maximum angulation between two implants which can be
managed is as follows:
· PF ⭋ 3.5 mm 6.0°
· PF ⭋ 4.0 mm 7.0°
· PF ⭋ 4.5 mm 8.5°
· PF ⭋ 5.0 mm 11.0°
7.6 mm
(minimum
construct
height)
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.
Platform ⭋
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.
Maximum
shortable
2.0 mm
Hexagon
type A
Hexagon
type B
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.
30°
For the framework modeling of the superstructure, the selected abutment is
aligned and placed on the analog, then fixed with the corresponding abutment screw.
4
© Thommen Medical
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 occlusal 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 suitable 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 instructions of the alloy manufacturer for the material used.
Material specification
VARIO screw seat
Nonoxidizing precious metal cast-on alloy
Melting interval
WAK 25–600 °C
Gold
Platinum
Palladium
Iridium
1400–1460 °C
12.8 μm/mk
60 %
24 %
15 %
1%
A
A
© Thommen Medical
5
The waxed-up crown or bridge framework must fit precisely within the abutment 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 precise 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.
A
STERILIZATION
Thommen abutments and components are not supplied in a sterile state.
Unless directed otherwise, a steam sterilization of the abutment is recommended:
· 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 productspecific performance qualification.
· Maximum sterilization temperature of 138 °C (280 °F; plus tolerance in
compliance with EN ISO 17665)
6
© Thommen Medical
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 inactivation. For further instructions on the sterilization of prosthetic components,
please refer to the respective valid Thommen Medical processing manuals.
3. General notes
Thommen Implant System
Responsibility/Liability
Guarantee
As a part of an overall scheme, Thommen implants
The comprehensive guarantees can be found in the
may be used only with the original components and
country-specific guarantee leaflets.
Manufacturer: Thommen Medical AG
instruments in accordance with the manufacturer`s
Neckarsulmstrasse 28
instructions. The use of the product is the responsibi-
General restrictions of use
2540 Grenchen, Switzerland
lity of the user, as such, beyond the control of Thom-
Restorations with cantilevers to individual implants
www.thommenmedical.com
men Medical AG. We refuse to accept any responsibi-
are not recommended.
Conformity symbol as specified by EU
lity or liability for any damage due to incorrect
Directive MDD 93/42/EEC
utilization of the product.
Consult instructions for use
Products labeled “Do not re-use” may not be refur-
Individual restorations with angled abutments should
not be used in regions with high mechanical stress.
Non-sterile
Catalogue number/Article number
Manufacturer
bished and/or reused. The refurbishment and/or reuse
For implants with a small diameter (PF ⭋ 3.5), the
of these products can affect their function (fitting and/
prosthetic restoration should be constructed in such
or cutting properties) as well as their safe use (risk
a way that large bending torque does not occur.
of infection, disease transmission, fading of the laser
or color marks, corrosion). Detailed information about
The abutments and/or auxiliary parts may not be
the possible consequences, which may result from
used on patients who are known to have allergies to
negligence to follow this information, is available
the corresponding materials.
Batch code
from your dealer. Caution: Federal law (USA) restricts
May only be sold to and prescribed by
this device to sale by or on the order of a dentist or
Possible complications
physicians (USA)
physician.
A stressed loading of the implant or abutment over
Do not re-use
Product information
bone loss or fracture of the implant or restoration.
The information given here on the intended purpose/
The clinician must supervise the occlusion and func-
restrictions of use describes the application of Thom-
tional loading of the prosthetic supraconstruction
men abutments. This information is available in elec-
very carefully.
and above its functional capacity can lead to excessive
Keep away from sunlight
tronic form online at: www.ifu-tm.com. For technical
A number of different abutments in various shapes
advice, please contact your Thommen Medical coun-
Warnings/Precautions
and sizes are available for the prosthetic restoration
try representative.
All components of the Thommen Implant System
of Thommen implants.
must be protected against aspiration.
Compatibility
Availability
The compatibility of Thommen abutments for Thom-
The Thommen abutments have not been evaluated for
Not all of the products mentioned in these instruc-
men ELEMENT and CONTACT implants has been
safety and compatibility in the MR environment. They
tions for use are available in all countries. Please
comprehensively established. The compatible size of
have not been tested for heating, migration, or image
consult with your country’s sales representative.
the connection point between the abutment and imp-
artifact in the MR environment. The safety of Thom-
lant is regulated by the platform size. So that the
men abutments in the MR environment is unknown.
Coloured warning sticker
abutment and implant can fit together, they must
Scanning a patient who has this device may result in
Application has changed - follow the instructions in
both be available in the same platform size. The plat-
patient injury.
the corresponding documentation.
form diameter is listed separately on the packaging
New design – the application has not been changed.
and is identified by a colour code, this also applies to
Validity
numerous auxiliary parts.
©Thommen Medical AG. All rights reserved. This
instruction for use replaces all previous editions.
ELEMENT &
CONTACT
Abutments
Platform
Color code
PF ⭋ 3.5 mm
PF ⭋ 4.0 mm
PF ⭋ 4.5 mm
PF ⭋ 5.0 mm
PF ⭋ 6.0 mm
PF ⭋-indipendent
Yellow
Green
Blue
Grey
Violet
Neutral
© Thommen Medical
7
AUSTRALIA/NEW ZEALAND
Osteon Medical
23/1866 Princess Highway
Clayton Victoria 3168 | Australia
Tel. (inside Australia): 1300 411 473
Tel. (outside Australia): +61 3 9264 0111
[email protected]
www.osteonmedical.com
AUSTRIA
Thommen Medical Austria GmbH
Simmeringer Hauptstrasse 24
1110 Wien | Austria
Tel. +43 1 93026 3014
Fax +43 1 93026 3015
[email protected]
BENELUX
Thommen Medical Benelux B.V.
Dierenriem 1
3738 TP Maartensdijk | Netherlands
Tel. +31 30 68 68 468
[email protected]
CANADA
Thommen Medical Canada Inc.
1100 Burloak Dr. | Suite 300
Burlington, ON L7L 6B2 | Canada
Tel. +1 (905) 336 8966
+1 877 242 6012 (North America)
Fax +1 (905) 332 3007
+1 877 242 6013 (North America)
[email protected]
CHINA
Shanghai Yujing Trading Co., Ltd.
15F-G | Jia Fa Bldg. | No. 129 | Da Tian Rd.
Shanghai 200041 | China
Tel. +86 21 62723077
Fax +86 21 62175264
CZECH REPUBLIC
BioVendor - Laboratorní medicína a.s.
Tůmova 2265/60 | 616 00 Brno | Czech Republic
Tel. +420 549 124 111 (sekretariát)
Fax +420 549 211 465
[email protected]
www.biovendor.cz/
FINLAND
Vector Laboratories Oy
Engelinaukio 8 B
00150 Helsinki | Finland
Tel. +358 400 940 700
labs@vektor.fi
HONG KONG
Shengyuan (Hong Kong) Int. Trade Co. Ltd.
Level 13, 68 Yee Wo Street
Causeway Bay | Hong Kong
Tel. +852 530 876 41
ITALY
Dental Trey S.r.l.
Via Partisani, 3
47016 Fiumana | Predappio (FC) | Italy
Tel. +39 0543 929111
Fax +39 0543 940659
[email protected]
www.dentaltrey.it
JAPAN
J. Morita Corporation
3-33-18, Tarumi-cho
Suita | Osaka 564-8650 | Japan
Tel. +81 6 6384 6921
Fax +81 6 6384 6746
www.morita.com
LITHUANIA/LATVIA
ČERNIKIS MEDICAL PROJECTS, UAB
Šiaurės prospektas 5B, Kaunas
Lithuania LT-49191
Tel.
+370 37 201072
Mobile +370 65 771550
[email protected]
www.cmp.lt
MIDDLE EAST
Star Science International GmbH
Jupiterstrasse 57
3015 Bern | Switzerland
Tel. +41 31 941 07 31
Fax +41 31 941 07 33
[email protected]
NORWAY
Novus Dental AS
Johannes Bruns gate 5
0452 Oslo | Norway
Tel. +47 951 07 007
[email protected]
www.novusdental.no
POLAND
C. Witt i Spółka Sp. z.o.o.
87-100 Toruń, ul. Św. Katarzyny 4/4 | Poland
Tel. +48 56 652 16 95
Fax +48 56 655 01 26
[email protected]
www.cwittdental.pl
SINGAPORE
FONDACO Pte Ltd
7 Kaki Bukit Road 1, #03-06
Eunos Techno Link
Singapore 415937 | Singapore
Tel. +65 6392 2806
Fax +65 6392 1296
[email protected]
SOUTH KOREA
APS Advanced Prosthetic Solution
201, Kolon Aston
505-14 Gasan-dong Geumchoen-gu
Seoul | South Korea
Tel. +82 2 3141 2875
Fax +82 2 3141 2877
www.apsdd.com
SPAIN/PORTUGAL
ISP Implante Suizo de Precisión
C/Los quintos n 1
03350 Cox (Alicante) | Spain
Tel. +34 96 536 1020
Fax +34 96 536 1188
[email protected]
SWITZERLAND
Thommen Medical AG
Neckarsulmstrasse 28
2540 Grenchen | Switzerland
Tel. +41 32 644 30 20
Fax +41 32 644 30 25
[email protected]
TAIWAN
Ting Sing Trading Co., Ltd.
No. 30 | Sec. 2 | Chang-An East Road
Taipei | Taiwan | R.O.C.
Tel. +886 2 25420968
Fax +886 2 25420969
www.tingsing.com.tw
TURKEY
Bioport Biyolojik Maddeler A.Ş.
Büyükdere cd. Subay evleri 9.Blok D1 Esentepe
Şişli 34394 Istanbul | Turkey
Tel. +90 212 2727577
Fax +90 212 2727628
[email protected]
www.bioport.com.tr
USA
Thommen Medical USA L.L.C.
1375 Euclid Avenue | Suite 450
Cleveland OH 44115 | USA
Tel. +1 866 319 9800 (toll free)
Fax +1 216 583 9801
[email protected]
[email protected]
can ar in i communications
SUBSIDIARIES/NATIONAL DISTRIBUTORS
GERMANY
Thommen Medical Deutschland GmbH
Am Rathaus 2
79576 Weil am Rhein | Germany
Tel. +49 7621 422 58 30
Fax +49 7621 422 58 41
[email protected]
RUSSIAN FEDERATION
CIS – JSC Geosoft
Build. 14, Ap. 16, 3-ya Mytishchinskaya ul.
Moscow, 129626 | Russian Federation
Tel. +7 495 663 22 11
[email protected]
06/16
Thommen Medical AG
Neckarsulmstrasse 28
2540 Grenchen | Switzerland
Tel. +41 61 965 90 20
Fax +41 61 965 90 21
[email protected]
FRANCE
Thommen Medical France
10 avenue Gabriel Pierné
77680 Roissy-en-Brie | France
Tel. +33 1 83 64 06 35
Fax +33 3 89 33 52 53
[email protected]
THM61136_VARIO17˚_EN_001_AA
HEADQUARTERS