510(k) K220287 ยท NXC Aligner, Sequential
Invisalign System
| Applicant | Align Technology, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 7, 2022 |
| Received | Feb 1, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Align Technology Inc Invisalign Express 10 REF 8512
Invisalign System Comprehensive REF 9000
Invisalign System Moderate REF 9001 Completed |
PNN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.