RS-Standard Internal Hex Plastic Surgical Kit-Starter
by Adin Dental Implant Systems LTD. EUDAMEDGUDID
Active
Ref RS6333Model Kit
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number729010515FullKitHE | Date20 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290105156389 | Date23 Apr 2017 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Dental implant/prosthesis surgical procedure kit
- Model / Reference
- Kit, RS6333
- Primary DI / UDI-DI
- 07290105156389
- Basic UDI-DI
- 729010515FullKitHE
- FDA Product Code
- OFY
- EMDN Code
- L159016 Dental surgery instrument kits, reusable
- GMDN Term
- Dental implant/prosthesis surgical procedure kit
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.3980
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000014625
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Adin Dental Implant Systems Ltd.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No