OBTURYS Handmix
OBTURYS Handmix (OBHM1-5) 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 2 Nov 2017 (UDI-DI 03760260221085), 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 | Number03760260221085 | Date2 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170207 | Date31 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 03760260221085
- FDA 510(k) database K170207
Across registries
- FDA 510(k) K170207 decided 31 Jul 2017 Active
- FDA GUDID UDI-DI 03760260221085 listed 2 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K170207
- Listed FDA GUDID 03760260221085
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- Withdrawn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
- Handmix, OBHM1-5
- Primary DI / UDI-DI
- 03760260221085
- 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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