Dental Direct Ti Base 2CUT noLock Set Instruction Manual

: October 31, 2023
: Dental Direct

Table of Contents

Dental Direct Ti Base 2CUT noLock Set
Product Information
Product Usage Instructions
Instructions for use
Product description
Cleaning/disinfection
Warranty
Explanation of symbols
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Dental Direct Ti Base 2CUT noLock Set

Product Information

The DD Ti-Base 2CUT noLock is a product made from Ti6Al4V (medical grade 5) ASTM 136 ELI. It includes the following components:

1 x DD Lab Screw, blue
1 x DD Implant Screw, silver

The product is designed for specific purposes and indications. It is intended for use by dental professionals and is compatible with various implant systems from different manufacturers.

Product Usage Instructions

Before using the product, please refer to the contraindications provided by the original implant manufacturer.
The DD Lab Screw should not be used for patient implant component integration.
The Implant Screw should be tightened with the system-specific torque (see table).
It is recommended to tighten the Implant Screw 10 minutes after placement.
Cleaning and disinfection can be done using manual cleaning procedures or other approved methods.
Sterilization can be achieved through an appropriate sterilization process.
After sterilization, store the product in a sterile packaging.
Follow the electronic instructions provided at www.dentaldirekt.de/IFU for additional guidance.
This product should only be sold by or on behalf of a dentist, as required by US federal law.
Do not reuse the product.

Please note that the torque values for specific implant systems can be found in the table provided in the user manual.

Instructions for use

Contents:

1 x DD Ti-Base 2CUT noLock (titanium bonding base, can be shortened, non-engaging)
1 x DD Lab Screw, blue
1 x DD Implant Screw, silver

Product description

The Dental Direkt Ti-Base 2CUT noLock is used as a titanium bonding base for customized bridge and bar restorations. The titanium bonding bases are available for various implant systems and consist of a prefab-ricated implant interface, a screw channel, a circumferential platform for shaping the emergence profile 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 bridge and bar restorations.

Contraindication:

Intolerance to the constituents
Restorations with an angulation correction of more than 25° 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 noLock that corresponds to the implant to be placed (see table). DD Ti-Base 2CUT no-Lock 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 tita-nium 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. In the case of long-span bridge restora-tions, care must be taken to ensure that the screw connections are free of stress. To avoid any stresses, the implant screws are tightened diagonally.

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 noLock, DD Implant Screw and DD Lab Screw are all made of Ti6Al4V (medical grade 5) ASTM 136 ELI.

Cleaning, disinfection and sterilization:
DD Solid Connect® implant components 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 compo-nents 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 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 noLock, 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. Diffe- rent 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 pro- duct 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

Dental-Direct-To-Base-2-CUT-noLock-Set-FIG-2

| 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