510(k) K261847 · NTK Light Transmission Caries Detector
iTero Lumina Pro
| Applicant | Align Technology , Ltd., Petach Tikva, IL |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Jun 3, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261847
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.