The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Fluoride Varnish.
| Device ID | K031932 |
| 510k Number | K031932 |
| Device Name: | FLUORIDE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-09-15 |
| Summary: | summary |