510(k) K160232 ยท PEM Dental Barriers And Sleeves
Disposable Barrier Sleeves and Covers
| Applicant | Dentsply International, Inc., York PA, US |
| Decision | Substantially Equivalent, Jun 7, 2016 |
| Received | Feb 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160232
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.