510(k) K202855 ยท DZB Headgear, Extraoral, Orthodontic
Orthodontic Facemask
| Applicant | Ita.O Italian Orthodontic System S.R.L., Villanova Di Castenaso, IT |
| Decision | Substantially Equivalent, Jun 21, 2021 |
| Received | Sep 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202855
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.