510(k) K193659 ยท NTK Light Transmission Caries Detector
iTero Element 5D
| Applicant | Align Technology, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Dec 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193659
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.