The following data is part of a premarket notification filed by Nanova Biomaterials, Inc. with the FDA for Starbright 5% Sodium Fluoride Varnish.
| Device ID | K140349 |
| 510k Number | K140349 |
| Device Name: | STARBRIGHT 5% SODIUM FLUORIDE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Contact | Andrew Ritts |
| Correspondent | Andrew Ritts NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-19 |
| Decision Date | 2014-09-22 |
| Summary: | summary |