The following data is part of a premarket notification filed by Preventive Technologies, Inc. with the FDA for Vella 5% Sodium Fluoride Varnish With Nufluor And Xylitol.
| Device ID | K140350 |
| 510k Number | K140350 |
| Device Name: | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL |
| Classification | Varnish, Cavity |
| Applicant | PREVENTIVE TECHNOLOGIES, INC. 4330C Matthews Indian Trail Rd Indian Trail, NC 28079 |
| Contact | Kenneth S Peterson |
| Correspondent | Kenneth S Peterson PREVENTIVE TECHNOLOGIES, INC. 4330C Matthews Indian Trail Rd Indian Trail, NC 28079 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-11 |
| Decision Date | 2014-12-12 |