# K242437: Smile Dx®

- Pathway: 510(k) (Traditional)
- Applicant: Cube Click, Inc.
- Decided: May 14, 2025 after 271 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P980025 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212519: Overjet Caries Assist, Overjet, Inc. (2022) Summary page 5.

## Most influential descendants
- K252086: DTX Studio Assist (2025), 0 descendants of its own

## Indications for use
Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy. Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of mesial and distal bone levels associated with each tooth. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment. Smile Dx® supports both digital and phosphor sensors.

Source page: https://510kreport.com/device/K242437
Methodology: https://510kreport.com/methodology