510(k) K213765 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Glidewell 3DP Denture Base Resin
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 22, 2022 |
| Received | Dec 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213765
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.