K191453 is an FDA 510(k) clearance for the Cervitec F. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on February 11, 2020, 256 days after receiving the submission on May 31, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K191453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2019 |
| Decision Date | February 11, 2020 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |