510(k) K252785 ยท EMA Cement, Dental
TopCEM Vigor SA Self-Adhesive Resin Cement
| Applicant | Rizhao Huge Biomaterials Company, Ltd., Rizhao, CN |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Sep 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252785
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.