510(k) K161580 ยท EBC Sealant, Pit And Fissure, And Conditioner
Premier Sealant
| Applicant | Premier Dental Company Products, Plymouth Meeting PA, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Jun 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161580
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.