The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Fluoride Varnish.
| Device ID | K093620 |
| 510k Number | K093620 |
| Device Name: | PULPDENT FLUORIDE VARNISH |
| Classification | Varnish, Cavity |
| Applicant | PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-03-10 |
| Summary: | summary |