The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Vlc Resin Cement.
| Device ID | K040236 |
| 510k Number | K040236 |
| Device Name: | PULPDENT VLC RESIN CEMENT |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-02 |
| Decision Date | 2004-04-20 |
| Summary: | summary |