Overjet CBCT Assist

Overjet CBCT Assist is cloud-based software that analyzes dental and craniomaxillofacial cone beam computed tomography (CBCT) images using artificial intelligence and machine learning. It provides automated segmentation of anatomical and restorative structures, user-directed or automated measurements, and 2D/3D visualizations to assist dental professionals in reviewing and interpreting CBCT images for diagnosis and treatment planning, but is not intended to replace clinician judgment.

The device is a web-based application focused exclusively on 3D CBCT volumetric data (DICOM format), offering multi-planar reconstruction, 3D volume rendering, virtual panoramic view reconstruction, AI-based segmentation of dental and craniomaxillofacial anatomy, and manual/automated measurement tools (distance, angle, area, signal intensity). Unlike predicate devices, it outputs PDF reports only and does not support 2D imaging modalities, intraoral scans, facial scans, or export to 3D planning formats (STL, OBJ).

Software verification and validation (V&V) testing followed FDA guidance 'General Principles of Software Validation' (January 2002) and the FDA-recognized consensus standard IEC 62304:2006+A1:2015 for software lifecycle processes. Testing included unit-level validation, integration testing, system verification, and user acceptance testing.

Overjet CBCT Assist is substantially equivalent because it shares the same regulatory classification (21 CFR 892.2050, Medical Image Management and Processing System), intended use (visualization and analysis of 3D CBCT data to assist diagnosis and treatment planning), and core functionality (AI-based segmentation, manual measurements, visualization tools) as predicates Relu Creator and Planmeca Romexis. Clinical performance testing on 100 retrospective CBCT scans demonstrated sensitivity for restorative structures of 87.0% and dental anatomy of 93.9%, meeting pre-specified performance goals and establishing safe and effective operation within intended use.