Endo-Seal
510(k) K971899
Endo-Seal is a medical device (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Ultradent Products, Inc., cleared under FDA 510(k) K971899 on 26 Jun 1997, 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 | NumberK971899 | Date26 Jun 1997 | StatusActive |
Official records
- FDA 510(k) database K971899
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- Withdrawn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).
- C-Root 1g by Beijing C-Root Dental Medical Devices Co., LTD.
- Tubli-Seal, Tubli-Seal EWT, Tubli-Seal Xpress, Tubli-Seal EWT Xpress by Sybron Dental Specialties, Inc.
- MTA MATERIAL by Dentsply Intl.
- BioRoot Flow 0.5g, BioRoot Flow 2g by Septodont
- DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S by Drfp, Ltd.
- ADSEAL Plus Resin Root Canal Filling by Meta Biomed Co., Ltd.
- DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S by Drfp, Ltd.
- ROOT CANAL FILLING RESIN by Dentsply Intl.
- Well-Root ST by VERICOM CO., LTD.
- MTA vpt 1645 by VOCO GmbH