510(k) K221450 ยท KLE Agent, Tooth Bonding, Resin
Phosphoric Acid Etching Gel
| Applicant | Rizhao Huge Biomaterials Company, Ltd., Rizhao City, CN |
| Decision | Substantially Equivalent, Sep 12, 2022 |
| Received | May 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221450
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.