The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Chemical Cure Pit And Fissure Sealant.
| Device ID | K945378 |
| 510k Number | K945378 |
| Device Name: | PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1995-01-17 |