The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Tuff-temp 2.0.
| Device ID | K120784 |
| 510k Number | K120784 |
| Device Name: | TUFF-TEMP 2.0 |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-06-08 |
| Summary: | summary |