The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Profluoro Fluoride Varnish.
| Device ID | K141422 |
| 510k Number | K141422 |
| Device Name: | PROFLUORO FLUORIDE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | PAC-DENT INTERNATIONAL, INC. 21038 Commerce Pointe Dr. Walnut, CA 91789 |
| Contact | Wenying Zhu |
| Correspondent | Wenying Zhu PAC-DENT INTERNATIONAL, INC. 21038 Commerce Pointe Dr. Walnut, CA 91789 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2014-09-30 |
| Summary: | summary |