Biotem FXBR6008RS
Biotem FXBR6008RS is a Class II device made by Biotem Co., ltd, cleared under FDA 510(k) K171297 on 31 Jan 2018 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 08800036204753), 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 | Number08800036204753 | Date1 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171297 | Date31 Jan 2018 | StatusActive |
Official records
- AccessGUDID record 08800036204753
- FDA 510(k) database K171297
Across registries
- FDA 510(k) K171297 decided 31 Jan 2018 Active
- FDA GUDID UDI-DI 08800036204753 listed 1 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K171297
- Listed FDA GUDID 08800036204753
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Biotem
- Generic name
- Dental implant system
- Model / reference
- FXBR6008RS
- Primary DI / UDI-DI
- 08800036204753
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental implant system.