510(k) K253282 ยท NXC Aligner, Sequential
ZSmile System
| Applicant | Dror Orthodesign , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Feb 3, 2026 |
| Received | Sep 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253282
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.