K253930

The Overjet Iris Intelligent Imaging System is AI-assisted dental imaging software — Overjet has built its business around AI-driven analysis of intraoral and panoramic radiographs for caries detection, bone-loss measurement, and workflow efficiency in dental practices. Product code QIH is the radiology image-management code Overjet typically files under despite the dental application.

Radiology panel, Traditional 510(k). Overjet's filings on this product code have come repeatedly as they've expanded the feature set — each meaningful analytic addition typically requires its own 510(k).

Overjet, Inc. files from Boston. Four-month review clock. The dental-AI imaging niche has been relatively uncongested compared to broader medical AI imaging, which tends to produce shorter timelines.