K131376 is an FDA 510(k) clearance for the SMARTCOAT 2.5% NAF VARNISH. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on August 27, 2013, 105 days after receiving the submission on May 14, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K131376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2013 |
| Decision Date | August 27, 2013 |
| Days to Decision | 105 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 |