K261847
- 510(k) number
- K261847
- Device name
- iTero Lumina Pro
- Applicant
- Align Technology , Ltd. IL
- Product code
- NTK — Light Transmission Caries Detector
- Decision date
- 2026-07-02
- Date received
- 2026-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261847.pdf
Official FDA record: K261847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.