510(k) K230333 ยท LBH Varnish, Cavity
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
| Applicant | Kettenbach GmbH & Co. KG, Eschenburg, DE |
| Decision | Substantially Equivalent, Jul 24, 2023 |
| Received | Feb 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230333
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.