510(k) K232012 ยท EHD Unit, X-Ray, Extraoral With Timer
N1
| Applicant | Osstem Implant Co., Ltd., Siheung-Si, KR |
| Decision | Substantially Equivalent, Nov 28, 2023 |
| Received | Jul 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232012
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.