Dental Direkt DD Ti-Base 2CUT Scanbody 2.0 Abutment Instruction Manual

Dental Direkt DD Ti-Base 2CUT Scanbody 2.0 Abutment

Product Information

• Product Name: DD Scanbody 2.0
• Description: The Dental Direkt Scanbody 2.0 is used for digital capture of the implant position relative to the remaining teeth and soft tissue. The scanbodies are intended for optical capture and are screwed into the implant or dental model as placeholders during intraoral scans. They are made of Ti6AI4V (medical grade 5) for single use and are delivered unsterile, each with a separately packaged implant screw and lab screw.
• Purpose: The DD Scanbody 2.0 is used for digital capture of the implant position in relation to the remaining teeth and soft tissue.
• Indication: The DD Scanbody 2.0 is indicated for use in dental scanning procedures.
• Contraindication: Please refer to the contraindications of the specific original implant manufacturer being used.
• Intended Users: Dental professionals
• Intended Patient Group: Patients requiring dental implant scanning
• Material: The DD Scanbody 2.0, DD Implant Screw, and DD Lab Screw are all made of Ti6Al4V (medical grade 5) ASTM 136 ELI.

Product Usage Instructions

1. The scanbody should be inserted into the cleaned osseous dental implant in the patient’s mouth using the silver-colored implant screw.
2. Note: The lab screw should not be used for the patient’s implant component assembly.
3. Note: The implant screw should be tightened with the system-specific torque (refer to the table).

Cleaning, Disinfection, and Sterilization

• Cleaning / Disinfection: Follow the manufacturer’s instructions for cleaning and disinfection. Alternatively, manual cleaning can be performed using an appropriate cleaning solution.
• Sterilization: After cleaning, the scanbody should be stored in a sterile package.
• For detailed electronic instructions, please visit www.dentaldirekt.de/IFU.
• Caution: According to US federal law, the product can only be sold by or on behalf of a dentist. Do not reuse.
• Manufacturer: Dental Direkt
• Manufacturing Date: [Insert manufacturing date]
• LOT Batch Designation: [Insert LOT batch designation]
• REF Catalog Number: [Insert catalog number]
• Storage: Store in a dry place
• Product Type: Medical device
• UDI: Unique Device Identification
• Dental Direkt Series: Compatible with various systems (refer to the table for specific torque values)

Contents

• 1 x DD Scanbody 2.0
• 1 x DD Lab Screw, blue
• 1 x DD Implant Screw, silver

Product description

• The Dental Direkt Scanbody 2.0 is used for digital acquisition of the implant position relative to the residual dentition and soft tissue. The scan bodies are intended for optical acquisition and are screwed into the im-plant as a placeholder for intraoral scans or into the laboratory analog in the dental model. They 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 scan bodies 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 digital acquisition of the implant position on the model or for short-term use in the mouth, relative to the residual dentition and soft tissue.
• 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
• 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:

• The Scanbody 2.0 is supplied with a Lab Screw for use on the model and with a silver Implant Screw for use in the patient‘s mouth. Before scan-ning, the surface must be clean and free of grease.
• The Scanbody 2.0 should be checked before scanning to make sure it does not show any signs of damage. Error-free scanning and exact repro-duction of the implant position is only assured if the Scanbody is intact and used correctly.
• Caution: Only use the Lab Screw in the model (max. torque: 10 Ncm).

Instructions for use in the dental practice:

• The Scanbody 2.0 is inserted with the silver Implant Screw into the cle-aned 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).

Material:

• Scanbody 2.0, DD Implant Screw and DD Lab Screw are all made of Ti6Al4V (medical grade 5) ASTM 136 ELI.

Cleaning, disinfection and sterilization:

• The Scanbody 2.0 and accompanying screws are cleaned at Dental Direkt, but not sterilized, before being packaged. Before they are used on the pa-tient, 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
• Caution: The Scanbody 2.0, DD Implant Screw and DD Lab Screw are suitable for single use only. Any reuse may lead to hazards due to infection.

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.

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
• 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
• 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
• 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

Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190 eIFU_DD Scanbody 2.0_Rev.03_20220601

References

• Dental Direkt - close to you
• Your search results | Dental Direkt
• eIFU - electronic Instructions for Use | Dental Direkt

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