(INOSS System) INOSS Fixture IBF-4516S
by Inosys, Inc.
(INOSS System) INOSS Fixture IBF-4516S is a Class II device made by Inosys, Inc., cleared under FDA 510(k) K260006 on 17 Jun 2026 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 00810112921854), 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 | Number00810112921854 | Date20 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260006 | Date17 Jun 2026 | StatusActive |
Official records
- AccessGUDID record 00810112921854
- FDA 510(k) database K260006
Across registries
- FDA 510(k) K260006 decided 17 Jun 2026 Active
- FDA GUDID UDI-DI 00810112921854 listed 20 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K260006
- Listed FDA GUDID 00810112921854
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- (INOSS System) INOSS Fixture
- Generic name
- Screw endosteal dental implant, two-piece
- Model / reference
- IBF-4516S
- Primary DI / UDI-DI
- 00810112921854
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, two-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional