Dental Direkt Ti-Base 2CUT Abutment with Shortenable Adhesive Base Instruction Manual

: June 13, 2024
: Dental Direkt

Dental Direkt Ti-Base 2CUT Abutment with Shortenable Adhesive Base Instruction Manual

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 instructions for use.

Intended patient group

Fixed restorations using Dental Direkt Solid Connect® implant components 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 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-

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 suitable 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. Different alloys in the oral cavity can lead to galvanic reactions when in direct contact.

Disposal

In compliance with local regulations.

Warranty

Our products undergo strict quality control and conform to the latest technical standards. Please refer to our current warranty terms for further details.

Please note: Any serious incident that occurs in connection with the product should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is located

Please note: The safety and clinical performance summary report can be requested at info@dentaldirekt.de.

We are continuously developing and enhancing our devices, and therefore reserve the right to make changes. The latest version of the instructions for use can also be found on our website at: www.dentaldirekt.de/en.

This version replaces all previous versions.

Explanation of symbols

Manufacturer

Date of manufacture

Batch code

Catalog number

Keep dry

Non-sterile

Do not use if package is damaged

Torque

Consult electronic instructions for use www.dentaldirekt.de/IFU

Caution: Under U.S. federal law, the device may only be sold by or on behalf of a dentist.

Do not re-use

Medical device

UDI Unique device identification

Dental Direkt Series| Compatible with: manufacturer| System| Size (mm)| Torque (Ncm)
---|---|---|---|---
DD AAS-Serie| Dentsply Implants®| Astra Tech®| 3,5 / 4,0| 25
4,5 / 5,0| 25
DD BSK-Serie| Bredent| Sky®| 3,5 NP| 25
4,0 / 4,5 RP| 25
DD CCA-Serie| Camlog®| Camlog®| 3,3| 20
3,8| 20
4,3| 20
5,0| 20
DD CCO-Serie| Camlog®| Conelog®| 3,3| 20
3,8| 20
4,3| 20
5,0| 20
DD DEV-Serie| Dentsply Implants®| Astra EV| 3,0| 25
3,6| 25
4,2| 25
4,8| 25
5,4| 25
DD DFX-Serie| Dentsply Implants®| Frialit®/Xive®| 3,4| 25
3,8| 25
4,5| 25
5,5| 25
DD MAR-Serie| MegaGen| AnyRidge®| 3,5 – 6,0| 30
DD MMI-Serie| Medentis Medical®| ICX| 4,1| 30
DD MSE-Serie| MIS Implants®| Seven®| 3,3 NP| 30
4,2 SP| 30
5,0 WP| 30
DD NBR-Serie| Nobel Biocare™| Brånemark| 3,5 NP| 35
4,1 RP| 35
DD NNA-Serie| Nobel Biocare™| Nobel Active™| 3,5 NP| 25
4,3 / 5,0 RP| 35
DD NRE-Serie| Nobel Biocare™| Replace Select®| 3,5 NP| 35
4,3 RP| 35
5,0 WP| 35
DD OTS-Serie| Osstem Implant| TS| 3,5 M| 20
4,0 – 6,0 R| 20
DD SBO-Serie| Straumann| Bone Level®| 3,3 NC| 35
4,1 / 4,8 RC| 35
DD SSY-Serie| Straumann| synOcta®| 4,8 RN| 35
6,5 WN| 35
DD TSP-Serie| Thommen Medical| SPI®| 3,5| 15
4,0| 25
4,5| 25
5,0| 25
6,0| 25
DD ZBC-Serie| Zimmer Biomet 3i| Certain®| 3,4| 30
4,1| 30
5,0| 30
DD ZTA-Serie| Zimmer Dental| Tapered Screw- Vent®| 3,5| 30
4,5| 30
5,7| 30