# K240573: iTero Lumina™ Pro

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Ltd.
- Decided: Aug 16, 2024 after 168 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: 6 generations back to K933455 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193659: iTero Element 5D, Align Technology, Inc. (2020) Summary page 5.

## Most influential descendants
- K261847: iTero Lumina™ Pro (2026), 0 descendants of its own

## 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/K240573
Methodology: https://510kreport.com/methodology