The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Seal Rite.
| Device ID | K911287 |
| 510k Number | K911287 |
| Device Name: | PULPDENT SEAL RITE |
| 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 | 1991-03-19 |
| Decision Date | 1991-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620708939900 | K911287 | 000 |