K072338 is an FDA 510(k) clearance for the CERVITEC PLUS. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on September 21, 2007, 32 days after receiving the submission on August 20, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K072338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2007 |
| Decision Date | September 21, 2007 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |