510(k) K912149 ยท EKJ Burnisher, Operative
HARDCOATED PLASTIC FILLING INSTRUMENT
| Applicant | Premier Dental Products Co., Norristown PA, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | May 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912149
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.