510(k) K261847
K261847 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 July 2, 2026. 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
- July 2, 2026
- Date Received
- June 3, 2026
- Clearance Type
- Special
- 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