The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Calcium Hydroxide Preparation.
| Device ID | K022734 |
| 510k Number | K022734 |
| Device Name: | PULPDENT CALCIUM HYDROXIDE PREPARATION |
| Classification | Resin, Root Canal Filling |
| 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 | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-16 |
| Decision Date | 2002-10-07 |
| Summary: | summary |