# K212519: Overjet Caries Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: May 10, 2022 after 273 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: 1 generation back to P980025 (1998). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980025: Logicon Caries Detector, Carestream Dental, LLC (1998) Summary page 6.

## Most influential descendants
- K222746: Overjet Caries Assist (2023), 9 descendants of its own
- K240003: Velmeni for Dentists (V4D) (2024), 2 descendants of its own
- K242437: Smile Dx® (2025), 1 descendant of its own
- K233738: Overjet Caries Assist-Pediatric (2024), 1 descendant of its own
- K261059: Overjet Multi-Image Caries and Charting Assist (2026), 0 descendants of its own

## Indications for use
The Overjet Caries Assist (OCA) 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. 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/K212519
Methodology: https://510kreport.com/methodology