The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Activa Presto Pack.
| Device ID | K210045 |
| 510k Number | K210045 |
| Device Name: | ACTIVA PRESTO PACK |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 |
| Contact | Lewis Berk |
| Correspondent | Lewis Berk Lewis Berk 80 Oakland Street Watertown, MA 02472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-08 |
| Decision Date | 2021-09-22 |