Profisil Free
510(k) K262243
Profisil Free is a Class II device made by Kettenbach GmbH & Co. KG, cleared under FDA 510(k) K262243 on 3 Sep 2026, 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 | FDA 510(k)SESE | NumberK262243 | Date3 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K262243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LBH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3260
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K262243
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Profisil 14823 | 14823 | E217148231 | — | On the market |
| Profisil 14825 | 14825 | E217148251 | — | On the market |
| Profisil 14833 | 14833 | E217148331 | — | On the market |
| Profisil 14834 | 14834 | E217148341 | — | On the market |
| Profisil 14839 | 14839 | E217148391 | — | On the market |
Similar devices
Other devices filed under FDA product code LBH (Varnish, Cavity).
- SCI-PHARM DFV VARNISH by SCIENTIFIC PHARMACEUTICALS, INC.
- Activ Varnish by Pulpdent Corporation
- SULTAN TOOTH ROOT DESENSITIZER by Dentsply International
- VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH by 3M Espe AG Dental Products
- TEMREX-DENTIN VARNISH by Temrex Corp.
- ACA THYROXINE ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc.
- HYDROL by Septodont
- GREEN-OR DENTIN DESENSITIZER by CENTRIX, INC.
- FLUOROSEAL, DENTIN SEALER AND CAVITY LINER by SCIENTIFIC PHARMACEUTICALS, INC.
- AQUEOUS ACRYLIC DISPERSION 28% W/W by Chx Technologies, Inc.