The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Embrace Wetbond Restoration And Pfm Repair Kit.
| Device ID | K032953 |
| 510k Number | K032953 |
| Device Name: | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-12-10 |
| Summary: | summary |