510(k) K230455 ยท EBC Sealant, Pit And Fissure, And Conditioner
Enamel Coating Resin
| Applicant | Rizhao Huge Biomaterials Company, Ltd., Rizhao City, CN |
| Decision | Substantially Equivalent, Jul 25, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230455
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.