Clearance Summary
iTero Lumina Pro received FDA 510(k) clearance under submission number K240573, sponsored by Align Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-08-16.
- Submission: K240573
- Applicant / Sponsor: Align Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2024-08-16
Classification & Regulation
This clearance is catalogued under FDA product code NTK and 21 CFR 872.1745, within the Dental review panel as a Class II device.