510(k) K182296 ยท EBF Material, Tooth Shade, Resin
HyperFil-LV
| Applicant | Parkell, Inc., Edgewood NY, US |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Aug 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182296
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.