# K251109: SMARTDent

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: May 21, 2025 after 40 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K173622 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173622: CS Imaging, Trophy (2018) Summary page 6.

## Indications for use
SMARTDent is intended for use as a software solution for managing dental diagnostic images and providing tools to support diagnosis.

Source page: https://510kreport.com/device/K251109
Methodology: https://510kreport.com/methodology