Clever One

Clever One is dental imaging software that enables trained medical professionals to load, view, and analyze DICOM-compliant medical images from CT, panoramic, cephalometric, and intraoral imaging equipment. It provides 2D and 3D visualization, measurement tools, implant simulation, and treatment planning support without making independent diagnostic or treatment decisions.

Clever One combines the 2D imaging capabilities of predicate EzDent-i with the 3D imaging capabilities of predicate Ez3D-i into a unified platform. Both operate on Windows 10+ with SQL databases, support DICOM image formats, include measurement tools (length, angle, circle, ROI/area, volume, profile), and provide identical image manipulation, annotation, and implant simulation features as the predicates.

Not stated in this summary.

Clever One is substantially equivalent because it integrates the validated technologies of two predicates (EzDent-i for 2D and Ez3D-i for 3D) without introducing new principles of operation or technological characteristics. The combined device uses identical DICOM processing, operates on the same Windows platform, includes all predicate functionalities unchanged, and underwent software verification/validation and measurement accuracy testing with passing results. The integration of 2D and 3D imaging into one interface does not raise new safety or effectiveness questions since both capabilities are already established in the predicates.