510(k) K190112 ยท EIH Powder, Porcelain
Non-Sterile Zirconia Block
| Applicant | Fine Advanced Compound Co., Ltd., Pyeongtaek, KR |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jan 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190112
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.