Dental Direkt ASTM 136 ELI DD Implant Screw Instruction Manual
- June 13, 2024
- Dental Direkt
Table of Contents
ASTM 136 ELI DD Implant Scre
DD Implant Screw
` `
Instructions for use
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany ·
Tel.: +49 5225 863190 1
eIFU_DD Implant Screw_Rev.01_20220601
Instructions for use
DD Implant Screw
Contents:
1 x DD Implant Screw, silver
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 endosseous 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.
Explanation of symbols:
Manufacturer
Date of manufacture
LOT Batch code
Catalog number
Keep dry
Non-sterile
Consult electronic instructions for use www.dentaldirekt.de/IFU
Do not re-use
Caution: Under U.S. federal law, the device may only be sold by or on behalf of a dentist.
Do not use if package is damaged
Explanation of symbols:
Medical device
UDI Unique device identification
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
References
- Dental Direkt - close to you
- Your search results | Dental Direkt
- eIFU - electronic Instructions for Use | Dental Direkt
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