K252785 is an FDA 510(k) clearance for the TopCEM Vigor SA Self-Adhesive Resin Cement. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 12, 2025, 101 days after receiving the submission on September 2, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K252785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 101 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 |