510(k) K191448 ยท PEM Dental Barriers And Sleeves
Barrier Sleeves
| Applicant | Ivoclar Vivadent, AG, Schaan, LI |
| Decision | Substantially Equivalent, Oct 8, 2019 |
| Received | May 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191448
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.