510(k) K222323 ยท PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Black Diamond
| Applicant | Elevate Oral Care, LLC, West Palm Beach FL, US |
| Decision | Substantially Equivalent, Jun 23, 2023 |
| Received | Aug 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222323
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.