510(k) K190043 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Halley resin
| Applicant | Dentsply Sirona, York PA, US |
| Decision | Substantially Equivalent, Apr 24, 2019 |
| Received | Jan 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190043
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.