510(k) K191774 ยท NXC Aligner, Sequential
SmileAlign Orthodontic Aligner System
| Applicant | 3D Global Biotech, Inc., New Taipei City 221, TW |
| Decision | Substantially Equivalent, Sep 30, 2019 |
| Received | Jul 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191774
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.