K160377 is an FDA 510(k) clearance for the V-varnish Premium. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on December 2, 2016, 296 days after receiving the submission on February 10, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K160377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2016 |
| Decision Date | December 02, 2016 |
| Days to Decision | 296 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 |