K210259 is an FDA 510(k) clearance for the Parkell Self-Adhesive Cement. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on January 20, 2022, 353 days after receiving the submission on February 1, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K210259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | January 20, 2022 |
| Days to Decision | 353 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |