# K250264: SugarBug (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Bench7, Inc.
- Decided: Nov 7, 2025 after 282 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 5.

## Indications for use
SugarBug is a radiological, automated, concurrent read, computer-assisted detection software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. Sugarbug is intended to be used on patients 18 years and older. 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.

Source page: https://510kreport.com/device/K250264
Methodology: https://510kreport.com/methodology