Diamodent B600
by Diamodent
Diamodent B600 is a Class II device made by Diamodent, cleared under FDA 510(k) K010619 on 28 Sep 2001 and listed in FDA GUDID since 4 Jan 2019 (UDI-DI D907B6000), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD907B6000 | Date4 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK010619 | Date28 Sep 2001 | StatusActive |
Official records
- FDA 510(k) database K010619
Across registries
- FDA 510(k) K010619 decided 28 Sep 2001 Active
- FDA GUDID UDI-DI D907B6000 listed 4 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K010619
- Listed FDA GUDID D907B6000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diamodent
- Generic name
- Dental prosthesis/implant abutment screw
- Description
- ComScrew, Gold Square 32 Ncm Gold alloy with 24k gold coating
- Catalogue number
- B600
- Primary DI / UDI-DI
- D907B6000
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Dental prosthesis/implant abutment screw
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Dry Heat Sterilization
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