# K231722: SmarTooth

- Pathway: 510(k) (Traditional)
- Applicant: Smartooth Co., Ltd.
- Decided: May 1, 2024 after 323 days
- Product code: NBL (Light-Induced Fluorescence 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: 2 generations back to DEN990002 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051909: Diagnodent, Kavo America (2005) Summary page 6.

## Indications for use
For use as an aid in the diagnosis of dental caries

Source page: https://510kreport.com/device/K231722
Methodology: https://510kreport.com/methodology