# K260851: Better Diagnostics Dental Assist (BDDA) Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Better Diagnostics AI Corp.
- Decided: Jul 15, 2026 after 121 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: 9 generations back to K930527 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 6.
- K210187: Overjet Dental Assist, Overjet, Inc. (2021) Summary page 6.

## Indications for use
Better Diagnostics Dental Assist (BDDA) Version 1.0 is a computer aided detection ("CADe”) software intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. The device is also intended to identify and mark regions in relation to suspected dental findings which include marginal discrepancy, calculus, periapical radiolucency (Only IOPA), crowns, filling and root canals. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists. The intended patient population of the device is patients who are 18 years or older and do not have any remaining primary teeth.

Source page: https://510kreport.com/device/K260851
Methodology: https://510kreport.com/methodology