510(k) K240573
K240573 is an FDA 510(k) premarket notification submitted by Align Technology , Ltd. for the device "iTero Lumina Pro". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Align Technology , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2024
- Date Received
- March 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type