AI company Overjet announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CBCT Assist platform. This approval expands Overjet’s AI capabilities to support interactive review and diagnostic interpretation of 3D CBCT dental scans.
The CBCT Assist platform is designed to help dental professionals assess anatomy, plan treatments, and make more precise diagnostic decisions. Using AI algorithms, it can automatically identify, label, segment, and measure anatomical and restorative structures, including bone levels, airway cross-sections, tooth-to-sinus or nerve distances, implant site bone height, and tooth impaction ratios.
“This FDA clearance, our 10th to date, marks a major milestone in advancing clinically validated AI in oral healthcare,” said Overjet CEO Dr. Wardah Inam. “We are committed to equipping dental providers with precise tools that support evidence-based treatment and improve patient care.”
CBCT Assist also integrates image enhancement features such as brightness and contrast adjustments, virtual panoramic reconstruction, and measurement tools for distance, area, angle, and signal intensity. Key clinical functions include:
Advanced Visualization: Multi-Planar Reconstruction (MPR) views and 3D volume rendering for comprehensive anatomical review.
Surgical Planning & Safety: Linear measurements aid third molar surgery planning near critical structures.
Implant Site Evaluation: Detailed measurements help assess bone availability and anatomy for implant placement.
Airway Health Assessment: Automatic reporting of minimum airway cross-sectional areas.
Parag Kachalia, DDS, Overjet’s head of clinical practice, emphasized, “This clearance is more than a regulatory milestone—it validates our scientific rigor and directly enhances diagnostic clarity, elevating care quality across dentistry.”
With this approval, Overjet strengthens its position as a leading provider of AI-driven clinical intelligence for dental treatment.