The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Temporary Crown And Bridge Material.
| Device ID | K081810 |
| 510k Number | K081810 |
| Device Name: | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02472 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021371 | K081810 | 000 |
| 00816519021364 | K081810 | 000 |
| 00816519021357 | K081810 | 000 |
| 00816519021340 | K081810 | 000 |