2
Version: 2 / 05. 2021
Compiled at: 19.05. 2021
Eff ective date: 19.05. 2021
Replaces version: 1 / 04. 2021
4097EN RE
V. 05/21 ©2021 Zfx GmbH
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Zfx GmbH |
Kopernikusstraße 15 | 85221 Dachau | Germany
Tel. +49 (0) 8131 / 33 244 - 0 | Fax +49 (0) 8131 / 33 244 - 10 | [email protected] | www.zfx-dental.com
Instruction Manual
GenTek
TM
Friction-Fit
Abutment Removal Tool
Indications for Use
The GenTek™ Abutment Removal Tools are used to disengage the friction-fi t
connection between an implant and abutment.
Device description
The GenTek™ Abutment Removal Tool is used to unseat / disassemble a
single-unit (engaging) fully-seated friction-fi t abutment from the corre-
sponding Zimmer Biomet Dental Implant upon the removal of the
abutment screw.
The connection systems containing friction-fi t are Eztetic
®
and TSV
®
/ TM™
Implant Systems. The friction-fi t varies by connection, there is a removal
tool for the narrow platform (NP – Eztetic) system, and a separate removal
tool for a a standard platform (SP – TSV / TM) system. The removal tool is not
intended to be used with GenTek™ Angulated Screw Channel Tibases.
Removal tool for
narrow platform (NP – Eztetic)
Removal tool for
standard platform (SP – TSV / TM)
The Removal Tool is intended to be driven using a hex driver-refer to the
product catalog for the corresponding hex driver.
Each tool is an individually packaged reusable component. The tool is
provided non-sterile and must be cleaned and sterilized prior to use in a
patient’s mouth.
Materials
GenTek™ Abutment Removal Tools are manufactured from Medical grade
Stainless Steel.
Procedure
1. Remove the fi nal retaining screw from the fully assembled abutment /
implant system using the applicable hex driver.
2. Using a hex driver, thread the corresponding removal tool through the
screw access channel in the fi nal restoration and rotate in a clockwise
direction until the abutment lifts / unseats from the implant.
× Cleaning and Sterilization
The GenTek™ Removal Tool is non-sterile. Prior to use, the tool must fi rst be
cleaned and sterilized. The tool can be used up to 5 cleaning / sterilization cycles.
Cleaning
1. Rinse the instrument under running cold tap water for 2 minutes.
2. Hand wash instruments in a bath with demineralized water for 5 minutes.
Remove debris with a soft brush. Cavities should be rinsed with a syringe. This
step should be repeated until all debris is removed.
3. Clean the instrument in an ultrasonic bath using a mildly alkaline cleaner
(1.5 %) at a frequency of at least 40 kHz for 20 minutes.
4. Rinse thoroughly with demineralized water for 1 min.
Sterilization
The recommended sterilization procedure is full cycle pre-vacuum steam
sterilization at a temperature of 134 °C (273.2 °F) for 3 minutes, 4 pulse mini-
mum or full cycle gravity steam sterilization at 134° C (273.2 °F) for 3 minutes
minimum. The products are ready for use 5 minutes after completion of the
autoclaving process.
Note:
Follow the loading instructions issued by the sterilizer manufacturer.
Storage
The GenTek™ Abutment Removal Tool should be stored at room temperature.
Contraindications
None
Known Side Eff ects
None
Warnings
×
The GenTek™ Abutment Removal Tool must only be used and handled by
dental professionals who have approved training in dentistry.
×
GenTek™ Abutment Removal Tool may only be used for Zfx GenTek and
Zimmer Biomet Dental branded abutments that contain friction fi t (excluding
Tibases containing an Angulated Screw Channel).
×
The GenTek™ Abutment Removal Tool are small and, therefore, they must be
handled with caution to avoid swallowing or inhaling by the patient.
×
The tool must be in good condition. A worn tool can lead to inability to
remove the restoration from the implant.
