# K193659: iTero Element 5D

- Pathway: 510(k) (Traditional)
- Applicant: Align Technology, Inc.
- Decided: Mar 20, 2020 after 81 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: 5 generations back to K933455 (1994). 7 ancestors in all.
2 later devices descend 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)
- K172007: CamX Triton HD Proxi Head, Duerr Dental AG (2017) Summary page 4.

## Most influential descendants
- K240573: iTero Lumina™ Pro (2024), 1 descendant of its own
- K261847: iTero Lumina™ Pro (2026), 0 descendants of its own

## Indications for use
The iTero Element 5D is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

Source page: https://510kreport.com/device/K193659
Methodology: https://510kreport.com/methodology