GBR Screw DBS1405
GBR Screw DBS1405 is a Class II device made by Dentis Co., Ltd, cleared under FDA 510(k) K222367 on 23 Mar 2023 and listed in FDA GUDID since 31 Mar 2023 (UDI-DI 08806169157232), active as of 23 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 | Number08806169157232 | Date31 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222367 | Date23 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 08806169157232
- FDA 510(k) database K222367
Across registries
- FDA 510(k) K222367 decided 23 Mar 2023 Active
- FDA GUDID UDI-DI 08806169157232 listed 31 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K222367
- Listed FDA GUDID 08806169157232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GBR Screw
- Generic name
- Dental regeneration membrane fixation tack, non-bioabsorbable
- Model / reference
- DBS1405
- Primary DI / UDI-DI
- 08806169157232
- 510(k) Number
- FDA product code
- DZL
- GMDN term
- Dental regeneration membrane fixation tack, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 872.4880
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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