K253248 is an FDA 510(k) clearance for the Bright Cavity Liner. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on January 13, 2026, 106 days after receiving the submission on September 29, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K253248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | January 13, 2026 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJK - Liner, Cavity, Calcium Hydroxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3250 |