510(k) K171585 ยท EIH Powder, Porcelain
LUXEN Zr, LUXEN Smile
| Applicant | Dentalmax Co., Ltd., Cheonan-Si, KR |
| Decision | Substantially Equivalent, Oct 31, 2018 |
| Received | May 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171585
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.