Dental Direct ASTM 136 Prefab Set Instruction Manual

: June 13, 2024
: Dental Direct

Table of Contents

Dental Direct ASTM 136 Prefab Set
Instructions for use
Product description
Intended users
Cleaning/disinfection
Warranty
Explanation of symbols
References
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Download This Manual (PDF format)

Dental Direct ASTM 136 Prefab Set

Instructions for use

Contents:

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

Product description

Dental Direkt Prefab blanks are prefabricated components for the machi-ning of customized, one-piece abutments using CAD/CAM technology. They are available for various implant systems and consist of a prefabrica-ted implant interface, screw channel, a retaining element for attachment in the milling machine and a groove for aligning the direction of rotation (axis of rotation). The cylindrical body located above the implant interface is transformed into the customized abutment design using computer-aided fabrication techniques. Dental Direkt Prefab blanks 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: The Dental Direkt Prefab blanks must only be used in combination with the DD Implant Library and the corresponding Prefab holder (incl. bar).

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 fabrication of individual abutments on implants in the upper and lower jaw.

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:
Make sure that the holder approved by Dental Direkt (DD prefab holder and DD prefab adapter) is used to clamp the blank in the CAD-CAM system. This holder ensures that the implant sits in the machine vibrati-on-free and is precisely orientated in the insertion direction. The prefab-ricated implant interface must not be modified during further processing. Damaged Prefabs must not be used. Always use suitable cooling and an extraction system when machining the blanks. Metal dusts are harmful to health, so always wear respiratory protection and safety goggles. The Prefab blank must not show any signs of damage. An undamaged and correct implant interface is essential for correct placement of the abutment.

Caution: When designing in CAD, ensure that the minimum wall thickness (0.4 mm) is observed.
Caution: If not machined properly, titanium can overheat and ignite.
Caution: Only use the Lab Screw in the model (max. torque: 10 Ncm).

Instructions for use in the dental practice:
The individual abutment is inserted with the silver Implant Screw into the cleaned endosseous dental implant located in the patient‘s mouth.

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

Cleaning, disinfection and sterilization:
DD Prefabs and accompanying screws are cleaned at Dental Direkt, but not sterilized, before being packaged. After machining, 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 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 Prefab, 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-ASTM-136-Prefab-Set-111111

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