The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Copal Varnish With Fluoride.
| Device ID | K100503 |
| 510k Number | K100503 |
| Device Name: | PULPDENT COPAL VARNISH WITH FLUORIDE |
| Classification | Varnish, Cavity |
| Applicant | PULPDENT CORPORATION 80 OAKLAND ST. Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 80 OAKLAND ST. Watertown, MA 02472 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-05-12 |
| Summary: | summary |