# K233738: Overjet Caries Assist-Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Mar 4, 2024 after 103 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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 4.

## Most influential descendants
- K261059: Overjet Multi-Image Caries and Charting Assist (2026), 0 descendants of its own

## Indications for use
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. 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. The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.

Source page: https://510kreport.com/device/K233738
Methodology: https://510kreport.com/methodology