510(k) K201787 ยท KLE Agent, Tooth Bonding, Resin
Light Cure Dental Adhesive
| Applicant | Rizhao Huge Biomaterials Company, Ltd., Rizhao City, CN |
| Decision | Substantially Equivalent, Sep 25, 2020 |
| Received | Jun 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201787
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.