Biodentine
510(k) K092251
Biodentine is a medical device (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Septodont, cleared under FDA 510(k) K092251 on 30 Oct 2009, 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 | FDA 510(k)SESE | NumberK092251 | Date30 Oct 2009 | StatusActive |
Official records
- FDA 510(k) database K092251
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KIF (Resin, Root Canal Filling).
- MTA ANGELUS by Angelus Industria DE Productos Odontologicos SA
- AH PLUS ROOT CANAL SEALER by Dentsply Intl.
- ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA by Wallace A. Erickson & Co.
- APEXIT ROOT CANAL SEALER by Williams Dental Co., Inc.
- ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) by MARUCHI
- Injectable Root Canal Bioceramic Sealer (nRoot SP) by Enpuno Co., Ltd.
- Well-Root ST WR102-K00C by VERICOM CO., LTD.
- ROOT CANAL XR by S & C Polymer GmbH
- HYDRON ROOT CANAL FILLING MATERIAL by National Patent Development Corp.
- MTA BIOSEAL Coffret MTA BIOSEAL MTA-BSEAL by ITENA CLINICAL