K153334 is an FDA 510(k) clearance for the Oral-B 5% Sodium Fluoride Varnish. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on May 20, 2016, 183 days after receiving the submission on November 19, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K153334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2015 |
| Decision Date | May 20, 2016 |
| Days to Decision | 183 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 |