The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Etch-rite Supreme.
| Device ID | K120213 |
| 510k Number | K120213 |
| Device Name: | ETCH-RITE SUPREME |
| 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 | 2012-01-24 |
| Decision Date | 2012-03-30 |
| Summary: | summary |