The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Glaze.
| Device ID | K020432 |
| 510k Number | K020432 |
| Device Name: | PULPDENT GLAZE |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| Subsequent Product Code | EBD |
| Subsequent Product Code | KLE |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-08 |
| Decision Date | 2002-04-17 |
| Summary: | summary |