510(k) K182338 ยท DYW Bracket, Plastic, Orthodontic
Blue Sky Bio Computerized Orthodontic Bracket System
| Applicant | Blue Sky Bio, Grayslake IL, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Aug 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182338
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.