Dental Direkt DD Ti-Base 2CUT Notice D'utilisation page 6

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Contents:
1 x DD Ti-Base 2CUT (titanium bonding base, can be shortened)
1 x DD Lab Screw, blue
1 x DD Implant Screw, silver
Product description:
The Dental Direkt Ti-Base 2CUT is used as a titanium bonding base for
customized crown and abutment restorations. The titanium bonding bases
are available for various implant systems and consist of a prefabricated
implant interface, a screw channel, a circumferential platform for shaping
the emergence profile, an anti-rotation protection that is used to align the
abutment in the vertical axis, and a cylinder that can be shortened for
customized patient care. Dental Direkt titanium bonding bases are made
of Ti6AI4V (medical grade 5) for single use and are supplied non-sterile,
each with a separately packaged Implant and Lab Screw.
Caution: Dental Direkt titanium bonding bases must only be used in
combination with the DD Implant Library.
Intended purpose:
DD Solid Connect® implant components are used to support prosthetic
restorations in combination with endosseous dental implants in the upper
and/or lower jaw.
Indication:
For attachment of customized crown and bar restorations, incl. an
anti-rotation protection for aligning the abutment in the vertical axis.
Contraindication:
• Intolerance to the constituents
• Restorations with an angulation correction of more than 30° to
the implant axis
Please note: Observe the contraindications specified by the original
implant manufacturer used in each case.
Intended users:
DD Solid Connect® implant components should only be used by dentists
and dental technicians in compliance with the procedures in the instruc-
tions for use.
Intended patient group:
Fixed restorations using Dental Direkt Solid Connect® implant compo-
nents are suitable for the permanent dentition in adult patients of any
gender and nationality.
Instructions for use in the laboratory:
In the laboratory, the technician selects the DD Ti-Base 2CUT that
corresponds to the implant to be placed (see table). DD Ti-Base 2CUT
is supplied with a chimney height of 6 mm. The chimney height can be
shortened at predefined grooves to a height of 5 mm or 4 mm by using a
0.3 mm thick fabric-reinforced cutting disc. The geometry of the titanium
bonding base must not be altered in any way except for shortening the
chimney height and removing the burr from the edges. Always use an
extraction system when cutting and sandblasting. Metal dusts are harmful
to health, so always wear respiratory protection and safety goggles.
During subsequent fabrication of prosthetic restorations, the minimum
wall thickness specified by the material manufacturer must be observed.
The individual restoration is constructed using dental design software. It is
possible to veneer a ceramic abutment using suitable veneering materials
and following the manufacturer's instructions. Veneering must always be
completed before bonding. The bonding surfaces of the titanium bonding
base must be treated with Al₂O₃ abrasives 110 μm and 2 bar max. before
bonding. The surfaces are bonded with a suitable luting material (e.g.
Multilink® Hybrid Abutment) in accordance with the manufacturer's
instructions. After curing, all adhesive residues on basal surfaces and in
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190
eIFU_DD Ti-Base 2CUT_Rev.08_20240219
Instructions for use
DD Ti-Base 2CUT
the screw channel must be carefully removed. The titanium bonding base
must not display any sign of damage. An undamaged and correct implant
interface is essential for correct placement of the prosthetic restoration.
Caution: On the model, only use the Lab Screw (max. torque: 10 Ncm).
Instructions for use in the dental practice:
The customized prosthetic restoration is placed in the patient's mouth
using the silver Implant Screw.
Caution: The Lab Screw must not be used for placement of the implant
components in the patient's mouth.
Caution: The Implant Screw must be tightened to the torque specified for
the system (see table).
Please note: It is recommended to tighten the Implant Screw 10 minutes
after placement.
Please note: When DD Solid Connect® implant components are used
for restorations with reduced-diameter implants, limited indications apply.
These can be found in the relevant instructions for use from the implant
manufacturer.
Please note: DD Solid Connect® implant components from a particular
series can only be combined with the corresponding compatible implant
system.
This also applies to the corresponding platform diameters.
Material:
DD Ti-Base 2CUT, DD Implant Screw and DD Lab Screw are all made of
Ti6Al4V (medical grade 5) ASTM 136 ELI.
Cleaning, disinfection and sterilization:
DD Ti-Base 2CUT and accompanying screws are cleaned at Dental Direkt,
but not sterilized, before being packaged. After customizing, and before
being used on the patient, the implant components must be cleaned,
disinfected and sterilized following the procedure described by Dental
Direkt.
Cleaning/disinfection:
Automatic cleaning in a suitable washer-disinfector with an appropriate
cleaning program for medical instruments (e.g. "Vario TD Program",
Miele).
OR
The following manual cleaning procedure:
• Rinse with cold tap water for 1 minute
• Rinse the screw channel using a disposable syringe
(min. capacity 10 ml)
• Clean in the ultrasonic cleaner at 60°C (140°F) +/- 2°C, e.g. using
Dr. Weigert neodisher® LM 2 for 10 minutes at a concentration of 5%
• Neutralize with cold distilled water for 2 minutes
• Rinse in the ultrasonic cleaner using distilled water at 60°C ( 140°F)
for 10 minutes
Sterilization:
Double-seal the products in sterilization film conforming to EN ISO 11607-
1. Steam sterilize in a suitable sterilizer with 3x fractionated prevacuum:
134°C (273°F) for 5 minutes, drying time: 20 minutes. Then store in
sterile packaging.
Caution: DD Ti-Base 2CUT, DD Implant Screw and DD Lab Screw are sui-
table for single use only. Any reuse may lead to hazards due to infection.
Possible side effects and interactions:
Allergic reactions or skin irritations are possible in very rare cases. Diffe-
rent alloys in the oral cavity can lead to galvanic reactions when in direct
contact.
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