510(k) K260788 ยท NXC Aligner, Sequential
Smylio Aligners
| Applicant | Smylio, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, May 8, 2026 |
| Received | Mar 10, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260788
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.