510(k) K190641 ยท DZE Implant, Endosseous, Root-Form
AR_N SLA Type Implant System
| Applicant | Biotem Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Mar 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190641
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.