510(k) K200908 ยท NXC Aligner, Sequential
iSMILE
| Applicant | 3D Diagnostix, Inc., Allston MA, US |
| Decision | Substantially Equivalent, Dec 22, 2020 |
| Received | Apr 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200908
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.