The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Putty Dam.
| Device ID | K022522 |
| 510k Number | K022522 |
| Device Name: | PULPDENT PUTTY DAM |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2002-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858395006356 | K022522 | 000 |