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Instruction Manual
GenTek™ Angulated Screw Channel
TiBase, Certain (12 mm Post)
Including fi nal prosthetic screw
*
Indications
Intended Use / Intended Purpose
The GenTek™ Angulated Screw Channel TiBase, an implant-level TiBase
system, along with the fi nal prosthetic screw is intended to support screw
and cement-retained single-unit (engaging), multi-unit (non-engaging),
and full-arch prosthetic restorations. It is used as an interface between a
dental implant and an abutment restoration. The GenTek™ Angulated
Screw Channel TiBase systems are intended to be used only with the
corresponding Gentek™ Hexalobular Screws (fi nal prosthetic screw and
Try-in Screw).
The gluing screw is intended for laboratory use during the cementing
process of the TiBase when the screw channel is straight. The gluing screw
is used to block the screw channel from the potential infl ow of glue while
the prosthetic restoration is being glued to the TiBase, prior to fi nal
placement of the TiBase and screw into the mouth.
Device description
Each GenTek™ Angulated Screw Channel TiBase is packaged with the fi nal
prosthetic screw and a black gluing screw. The fi nal prosthetic screw for
each system is also available as an individually packaged component. The
TiBase, prosthetic screw, and gluing screw are for single use only. The
TiBase and prosthetic screw are provided non-sterile and intended to be
cleaned and sterilized prior to placement into the patient's mouth.
The GenTek™ Angulated Screw Channel TiBases allow the placement of the
screw channel up to 25° at 360° rotation. The TiBase contains an overall
post height of 12 mm with horizontal cutting grooves to indicate height
adjustments at 4.5 mm, 6.5 mm, and 8.5 mm. Additionally, the GenTek™
Angulated Screw Channel TiBases contain 3 vertical anti-rotation grooves
designed to prevent the restoration from rotating. The GenTek™ Angulated
Screw Channel Tibases containing a 12 mm post height are available with
the Certain genuine connection.
Anti-Rotation Grooves
SLA Grooves
For specifi c dental implant compatibility, please refer to the information on
the individual product label and the GenTek™ components catalog.
Materials
GenTek™ TiBases are manufactured from biocompatible titanium alloy
grade 5 ELI (TiAl6V4 ELI).
Zfx GmbH |
Kopernikusstraße 15 | 85221 Dachau | Germany
Tel. +49 (0) 8131 / 33 244 - 0 | Fax +49 (0) 8131 / 33 244 - 10
info@zfx-dental.com | www.zfx-dental.com
*
Angulated Screw Channel
12.0 mm
8.5 mm
6.5 mm
4.5 mm
Version: 3 / 01. 2022
Compiled at: 28. 01. 2022
Eff ective date: 01. 03. 2022
Replaces version: 2 / 05. 2021
Procedure
×
Designing the Custom Restoration
The GenTek™ TiBase can be processed via a digital or traditional workfl ow
utilizing GenTek™ Scan Bodies. The custom restoration must be constructed
using dental design software. The geometry of the TiBase abutment is
contained in the library fi le. Minimum wall thickness requirements should be
controlled according to the material supplier's recommendations.
×
Milling a Custom Restoration
The custom restoration must be manufactured with milling equipment
adequate for the designed geometry and material of the restoration.
×
Post-Processing the Custom Restoration
Follow the post-processing steps in accordance with the instructions issued
by the material supplier.
×
Preparing the Custom Restoration for Cementing
Once the custom restoration is ready for cementing, refer to the material
supplier's instructions for use for proper cementing process.
×
Preparing the GenTek™ TiBase for Cementing
Before cementing the restoration (crown or framework) to the abutment, the
gluing surface of the TiBase should be thoroughly cleaned as outlined in the
Cleaning and Sterilization section of this IFU. Blast GenTek™ TiBase in
accordance with the instructions issued by the cement supplier.
The post of the GenTek™ Angulated Screw Channel TiBases has a maximum
height of 12 mm and contains 3 cutting grooves which indicate 4.5 mm,
6.5 mm, and 8.5 mm post heights. The abutment can be left at its maximum
post height of 12 mm or it can be cut at one of the three indicated heights
that best fi ts the case so that the prosthetic can be digitally designed from
the corresponding library fi le. Abutments may be cut per standard laboratory
practices and procedures and should not be cut back below the 4.5 mm
grove.
×
Cementing
Follow cementing procedures in accordance with the instructions issued by
the cement supplier. In order to cement the restoration to TiBase, insert the
base into an implant analog and fi x it in place with the gluing screw (fi nger-
tighten). The gluing screw should be kept in place throughout the cementing
process. The gluing screw should not be used when the channel is angulated
on the restoration. Apply the cement in a circular fashion to the top edge of
the contact surface of the TiBase and to the internal geometry of the
restoration. Rotate the restoration gently as you push it over the TiBase until
resistance is felt. The GenTek™ Angulated Screw Channel TiBases, single-unit
and multi-unit, contain anti-rotation grooves that the restoration needs to be
aligned to prior to reaching its fi nal position.
Note:
Avoid raising the restoration after the fi nal position has
been reached, as this can compromise the integrity of the bond.
The custom restoration must fi t the GenTek™ TiBase without gaps
and voids. Any traces of cement should be removed immediately.
The restoration must be held in position during cement
removal.
×
Polishing
Once the cement has set, remove the excess cement with rubber polishing
tools. When polishing, fi x the TiBase / restoration in an implant analog to
prevent damaging the connection geometry.
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