# K241725: Better Diagnostics Caries Assist (BDCA) Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Better Diagnostics AI Corp.
- Decided: Mar 11, 2025 after 270 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: 3 generations back to P980025 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222746: Overjet Caries Assist, Overjet, Inc. (2023) Summary page 6.

## Indications for use
Better Diagnostics Caries Assist is a radiological, automated, concurrent read, CADe software intended to identify and localize carious lesions on bitewings and periapical radiographs acquired from patients aged 18 years or older. Better Diagnostics Caries assist is indicated for use by board licensed dentists. 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 or actual in vivo clinical assessment.

Source page: https://510kreport.com/device/K241725
Methodology: https://510kreport.com/methodology