The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Hard Core.
| Device ID | K922755 |
| 510k Number | K922755 |
| Device Name: | PULPDENT HARD CORE |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1992-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D701HCR2 | K922755 | 000 |
| D701HC2 | K922755 | 000 |