The following data is part of a premarket notification filed by Parkell, Inc with the FDA for Parkell Self-adhesive Cement.
| Device ID | K210259 |
| 510k Number | K210259 |
| Device Name: | Parkell Self-Adhesive Cement |
| Classification | Cement, Dental |
| Applicant | Parkell, Inc 300 Executive Drive Edgewood, NY 11717 |
| Contact | La-shaunda Joseph |
| Correspondent | La-shaunda Joseph Parkell, Inc 300 Executive Drive Edgewood, NY 11717 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2022-01-20 |