# K261847: iTero Lumina™ Pro

- Pathway: 510(k) (Special)
- Applicant: Align Technology, Ltd.
- Decided: Jul 2, 2026 after 29 days
- Product code: NTK (Light Transmission Caries Detector)
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933455 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240573: iTero Lumina™ Pro, Align Technology, Ltd. (2024) Summary page 5.

## Indications for use
The iTero Lumina Pro NIRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.

Source page: https://510kreport.com/device/K261847
Methodology: https://510kreport.com/methodology