510(k) K182193 ยท NJM Bracket, Ceramic, Orthodontic
S-Line
| Applicant | Biocetec Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 22, 2019 |
| Received | Aug 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182193
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.