OBTURYS Automix
OBTURYS Automix (OBAX1-5) is an endodontic filling/sealing material (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Itena Clinical, cleared under FDA 510(k) K170207 on 31 Jul 2017 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 03760260221092), 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 | Number03760260221092 | Date31 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170207 | Date31 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 03760260221092
- FDA 510(k) database K170207
Across registries
- FDA 510(k) K170207 decided 31 Jul 2017 Active
- FDA GUDID UDI-DI 03760260221092 listed 31 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K170207
- Listed FDA GUDID 03760260221092
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Obturys
- Generic name
- Endodontic filling/sealing material
- Model / Ref / Catalog
- Automix, OBAX1-5
- Primary DI / UDI-DI
- 03760260221092
- 510(k) Number
- FDA product code
- KIF
- GMDN term
- Endodontic filling/sealing material
- Device class
- Class II
- Regulation number
- 872.3820
- GUDID distribution status
- In Commercial Distribution
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