510(k) K191427 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Halley resin system
| Applicant | Dentsply Sirona, York PA, US |
| Decision | Substantially Equivalent, Aug 26, 2019 |
| Received | May 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191427
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.