Sirona TiBase User manual

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Operating Instructions

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Table of contents Sirona Dental Systems GmbH
Operating Instructions TiBase
Table of contents
1Symbols used........................................................................................................... 3
2Product description................................................................................................... 4
3Materials................................................................................................................... 7
4Intended use, indications and contraindications....................................................... 8
4.1 Intended use ................................................................................................. 8
4.2 Indications ..................................................................................................... 8
4.3 Contraindications .......................................................................................... 8
5Processing hints ....................................................................................................... 9
5.1 Scanning ....................................................................................................... 9
5.2 Processing the TiBase .................................................................................. 10
5.3 Information for the dentist ............................................................................. 11
5.3.1 Sterilization....................................................................................... 11
5.3.2 Application in the mouth................................................................... 11

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Sirona Dental Systems GmbH 1Symbols used
Operating Instructions TiBase
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1Symbols used
NOTICE! Observe operating instructions!
This product is a medical device in accordance with Council Directive 93/
42/EEC.
For the USA only
CAUTION: Federal law (USA) restricts sale of this device to or on the
order of a physician, dentist, or licensed practitioner.
Article number
Batch number
This product is intended for single use only
unsterile
0123
NON
STERILE

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2Product description Sirona Dental Systems GmbH
Operating Instructions TiBase
2Product description
TiBase and Abutment Screw are products which are used for the digital
acquisition of an implant position and for the restorative supply of
implants.
Instead of a deformation post to transmit the implant position to a model,
a Scanbody is required in the digital process, which can be optically
acquired in an effective way along with the mouth situation. For this
purpose, a titanium base (product name: TiBase) is mounted on an
implant or laboratory analog with an Abutment Screw (product name for
separate product: Abutment Screw) and depending on the acquisition
system a suitable Scanbody is connected to this.
The titanium base is designed on the bottom side in line with the implant’s
specific requirements and can only be screwed onto specific implants
with a certain diameter. The top side is formed for the acquisition of a
Scanbody.
A titanium base can also be used for the restorative supply of an implant.
For this purpose, a mesostructure is glued onto the titanium base, which
can be individually adjusted in line with aesthetic and functional
requirements. Depending on the mesostructure design, the product glued
to the titanium base can be used as the abutment or directly bolted crown.
An Abutment Screw is also used for the definitive attachment to the
implant.
The TiBase product comprises two individual components: Titanium base
and Abutment Screw.
The Abutment Screw product comprises two identical Abutment Screws.
Abutment Screws are provided separately, as they are either required as
a replacement part or as an additional attachment to the laboratory
analog.

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Sirona Dental Systems GmbH 2Product description
Operating Instructions TiBase
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Table 1: Overview of the TiBase, Abutment Screws and tightening
torques

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2Product description Sirona Dental Systems GmbH
Operating Instructions TiBase
Depending on the connection, the following components are compatible:
Table 2: Overview of compatible Scanbodies and mesostructure blocks
Connection Scanbodies for
Omnicam
Scanbodies for
Bluecam
inCoris ZI meso F0.5 inCoris ZI meso F2
S 6431329 6431303 6231810 6231836
L 6431311 6431295 6231802 6231828

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Sirona Dental Systems GmbH 3Materials
Operating Instructions TiBase
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3Materials
TiBase, abutment screw Ti6Al4V, medical grade 5, ASTM
136

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4Intended use, indications and contraindications Sirona Dental Systems GmbH
4.1Intended use Operating Instructions TiBase
4Intended use, indications and
contraindications
4.1 Intended use
Titanium base for manufacturing a two-part abutment, comprising TiBase
and inCoris ZI mesostructure.
For the USA only
CAUTION: Federal law (USA) restricts sale of this device to or on the
order of a physician, dentist, or licensed practitioner.
4.2 Indications
TiBase titanium bases are attached to an implant as prosthetic titanium
base for adhesion to mesostructures to restore function and aesthetics in
the oral cavity.
4.3 Contraindications
● Insufficient oral hygiene
● Insufficient space available
● Bruxism
● For restorations with angulation correction of more than 20° to the
implant axis
● For individual tooth restorations with free end saddle
● For restorations whose length exceeds a ratio of 1:1.25 in
comparison to the length of the implant

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Sirona Dental Systems GmbH 5Processing hints
Operating Instructions TiBase 5.1Scanning
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5Processing hints
5.1 Scanning
1. Mount the TiBase on the matching laboratory analog in the master
model or onto the implant in the mouth of the patient and screw it tight
using the supplied abutment screw. In doing so, it is insignificant in
which direction the small cam on the top side of the titanium base
points.
2. Plug a suitable Scanbody (see Table 2 in the Section “Product
description [ → 4]“) onto the TiBase so that it is seated free of gaps,
and therefore flush while watching out for the intended guide groove
in the Scanbody, guide it over the small cam on the TiBase. The
scanbody is scannable without powder or scan spray.
3. Acquire the situation alternatively with inEos X5, inEos Blue, CEREC
3 or CEREC AC.
4. Use the CEREC SW/inLab SW software to design the individual
shape of the mesostructure and mill the shape from one of the
materials allowed for this purpose (e.g., inCoris ZI meso). Be sure to
observe the information on design, post-processing and gluing with
the TiBase provided in the Operating Instructions/Processing
Instructions for the corresponding material.
CAUTION
Intraoral application
The TiBase should only be used in the mouth once the correct
positioning of the Scanbody has been checked without any concerns.
This is difficult to perform on deeply positioned implants. In such cases,
ScanPost is recommended.

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5Processing hints Sirona Dental Systems GmbH
5.2Processing the TiBase Operating Instructions TiBase
5.2 Processing the TiBase
The diameter of the TiBase must not be reduced e.g. by grinding.
Shortening the TiBase is not permitted.
The contact surfaces of the TiBase to the implant should not be sand-
blasted or otherwise processed.
Only the surfaces of the TiBase intended for gluing with a mesostructure
must be sandblasted (50µm aluminum oxide, max. 2.0 bar) and then
cleaned (with alcohol or steam).
Use "PANAVIA ™ F 2.0" (www.kuraray-dental.de) as an adhesive
extraorally to connect the TiBase and the sintered inCoris ZI
mesostructure. Other glues are required for attaching different materials.
Observe the operating instructions for the material used.
1. For easier handling during the gluing process, it is recommended that
the TiBase be screwed into a lab implant or a polishing tool.
2. Cover the hex head of the abutment screw with wax.
3. Sand-blast the gluing surfaces of the TiBase with 50 µm aluminum
oxide and up to 2.0 bar and clean the surfaces with alcohol or steam.
4. Ensure that the mesostructure can be fully slid onto the TiBase.
5. Apply metal primer and glue to the TiBase while observing the
manufacturer specifications.
6. Push the sintered inCoris ZI mesostructure in as far as it will go. Make
sure it latches into the rotation and position stops.
7. Remove excess glue immediately. Make sure that there is no glue
residue left in the screw channel.
8. Follow the recommendations of the glue manufacturer with regard to
the final hardening of the glue.
9. Remove residue with a rubber polisher after hardening.

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Sirona Dental Systems GmbH 5Processing hints
Operating Instructions TiBase 5.3Information for the dentist
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5.3 Information for the dentist
The titanium bases TiBases are delivered in non-sterile condition.
Observe the implant manufacturer's operating instructions.
5.3.1 Sterilization
The individual abutments and abutment screws must be cleaned and
sterilized prior to insertion. Furthermore, the locally applicable legal
regulations and the hygiene standards applicable for a dental practice
must be observed.
Use only the validated sterilization procedures specified below to sterilize
individual abutments. Observe the sterilization parameters.
Use a steam sterilizer to sterilize the unwrapped individual abutment and
screw with a pre-vacuum cycle (135°C / 275° F for 3 minutes).
The responsibility for the sterility of the individual abutment lies with the
user. It must be ensured that only suitable devices, materials and
product-specifically validated methods are used to perform sterilization. It
must be ensured that the methods used have been validated. The
equipment and devices must be properly maintained and serviced at
regular intervals.
The fabricator (dental technician) of the TiBase and the mesostructure
must inform the dentist of the need to sterilize the abutment before
inserting it in the patient's mouth!
5.3.2 Application in the mouth
WARNING
Risk of aspiring small parts
➢Position the patient in such a way that the risk of aspiring small parts
is kept to a minimum.
➢Secure all intraorally used components against aspiration and being
swallowed.
WARNING
Use the unused Abutment Screw and the tools provided by the implant
manufacturer to screw the TiBase onto the implant, observing the
tightening torques specified in table 1 (see “Product description [ → 4]“).

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