# K241684: Overjet Charting Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Aug 27, 2024 after 77 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K930527 (1993). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233590: Overjet Charting Assist, Overjet, Inc. (2024) Summary page 5.

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

## Indications for use
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history. This device includes a Predetermined Change Control Plan (PCCP).

Source page: https://510kreport.com/device/K241684
Methodology: https://510kreport.com/methodology