K242366 is an FDA 510(k) clearance for the OverCEM SA Universal. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Overfibers S.R.L. (Imola (Bo), IT). The FDA issued a Cleared decision on January 10, 2025, 154 days after receiving the submission on August 9, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K242366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 154 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 |