510(k) K242749 ยท KLE Agent, Tooth Bonding, Resin
TopCEM Ceramic Primer Ceramic Coupling Agent
| Applicant | Rizhao Huge Biomaterials Company, Ltd., Rizhao, CN |
| Decision | Substantially Equivalent, Nov 8, 2024 |
| Received | Sep 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242749
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.