K212475 is an FDA 510(k) clearance for the Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra). This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on May 13, 2022, 280 days after receiving the submission on August 6, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K212475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2021 |
| Decision Date | May 13, 2022 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJK - Liner, Cavity, Calcium Hydroxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3250 |