510(k) K191591 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
BB Base 3D printing resin for denture base
| Applicant | Enlighten Materials Co., Ltd., Taipei, TW |
| Decision | Substantially Equivalent, Aug 18, 2020 |
| Received | Jun 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191591
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.