K240573
- 510(k) number
- K240573
- Device name
- iTero Lumina Pro
- Applicant
- Align Technology , Ltd. IL
- Product code
- NTK — Light Transmission Caries Detector
- Decision date
- 2024-08-16
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240573.pdf
Official FDA record: K240573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.