Dental Direkt AAS-Series DD Implant Screw Instruction Manual

: June 1, 2024
: Dental Direkt

Table of Contents

Contents:
Product description:
Intended purpose:
Indication:
Contraindication:
Intended users:
Intended patient group:
Instructions for use in the dental practice:
Material:
Cleaning, disinfection and sterilization:
Cleaning/disinfection:
Sterilization:
Possible side effects and interactions:
Disposal:
Warranty:
Explanation of symbols:
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Dental Direkt AAS-Series DD Implant Screw Instruction Manual

Dental Direkt AAS-Series DD Implant Screw Instruction
Manual

Product description:

The Dental Direkt Implant Screw is an accessory for the Solid Connect® products and can only be used in combination with them. It is used for fixation between abutment, titanium bonding base or scan body and implant. The Implant Screw is available for different implant systems.
The Dental Direkt Implant Screw is made of Ti6AI4V (medical grade 5) for single use and is supplied non-sterile.

Intended purpose:

DD Solid Connect® implant components are used to support prosthetic restorations in combination with end osseous dental implants in the upper and/or lower jaw.

Indication:

For fixation of individual abutments, titanium bonding bases or scan bodies to implants in the upper and lower jaw
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 platform diameters.

Contraindication:

Intolerance to the constituents
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 dental practice:

The individual prosthetic restoration is placed in the patient’s mouth using the silver Implant Screw.
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.

Material:

The DD Implant Screw is made of Ti6Al4V (medical grade 5) ASTM 136 ELI.

Cleaning, disinfection and sterilization:

The Implant Screw is cleaned at Dental Direkt, but not sterilized, before being packaged. Before being used on the patient, the Implant Screw 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: The DD Implant Screw is 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 products, 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.