# K251514: Overjet CBCT Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Dec 5, 2025 after 203 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: 12 generations back to K954678 (1996). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233925: Relu Creator, Relu BV (2024) Summary page 6.
- K200572: Planmeca Romexis, Planmeca Oy (2020) Summary page 6.

## Indications for use
Overjet CBCT Assist is a software for the analysis of dental and craniomaxillofacial Cone Beam Computed Tomography (CBCT) images. The software utilizes artificial intelligence/machine learning algorithms to provide automated segmentations, user-delineated or automated measurements, and 2D/3D visualizations. These tools are intended to assist dental professionals in their review and interpretation of CBCT images by facilitating anatomical assessment and supporting their diagnostic and treatment planning process. The device is not intended as a replacement for a complete clinician’s review or their clinical judgement.

Source page: https://510kreport.com/device/K251514
Methodology: https://510kreport.com/methodology