510(k) K191524 ยท KLE Agent, Tooth Bonding, Resin
Visalys Tooth Primer
| Applicant | Kettenbach GmbH & Co. KG, Eschenburg, DE |
| Decision | Substantially Equivalent, Sep 29, 2019 |
| Received | Jun 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191524
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.