OSSIX Agile™ 68018006
OSSIX Agile™ 68018006 is a Class II device made by Datum Dental Ltd, cleared under FDA 510(k) K212509 on 18 Jul 2022 and listed in FDA GUDID since 5 Jun 2023 (UDI-DI 07290015477369), 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 | Number07290015477369 | Date5 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212509 | Date18 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 07290015477369
- FDA 510(k) database K212509
Across registries
- FDA 510(k) K212509 decided 18 Jul 2022 Active
- FDA GUDID UDI-DI 07290015477369 listed 5 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K212509
- Listed FDA GUDID 07290015477369
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OSSIX Agile™
- Generic name
- Collagen dental regeneration membrane
- Model / reference
- 68018006
- Primary DI / UDI-DI
- 07290015477369
- 510(k) Number
- FDA product code
- NPL
- GMDN term
- Collagen dental regeneration membrane
- Device class
- Class II
- Regulation number
- 872.3930
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 20 MillimeterLength — 30 Millimeter
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