510(k) K190837 ยท DZE Implant, Endosseous, Root-Form
Internal Hex Implant System
| Applicant | Ebi, Inc., Gyeongsan-Si, KR |
| Decision | Substantially Equivalent, Jan 22, 2020 |
| Received | Apr 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190837
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.