# K261059: Overjet Multi-Image Caries and Charting Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Aug 6, 2026 after 128 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: 14 generations back to K930527 (1993). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 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.
- K241684: Overjet Charting Assist, Overjet, Inc. (2024) Summary page 6.
- K233738: Overjet Caries Assist-Pediatric, Overjet, Inc. (2024) Summary page 6.

## Indications for use
Overjet Multi-Image Caries and Charting Assist is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings. The device uses AI/ML algorithms to analyze all available dental radiographs of the patient jointly, evaluating findings at the patient-tooth level, to support the clinician's review. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment. The device is intended to detect caries on bitewing (BW) and periapical (PA) radiographs in patients 4 years of age and older, with visual differentiation between incipient caries, non-incipient caries and secondary caries. The device is intended to detect tooth anatomy, tooth numbering, and past restorative treatments on bitewing (BW) and periapical (PA) and panoramic (Pano) radiographs in patients 4 years of age and older.

Source page: https://510kreport.com/device/K261059
Methodology: https://510kreport.com/methodology