Overjet, the leader in artificial intelligence (AI) for dental organizations, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Overjet CBCT Assist. This clearance expands Overjet's AI platform to enable interactive review and support diagnostic interpretation of 3D CBCT data, further solidifying its position as the most comprehensive clinical intelligence AI solution in dentistry.
With this new clearance, Overjet’s clinical intelligence platform extends its AI capabilities to cone beam computed tomography (CBCT) imaging. Overjet’s CBCT Assist product will assist dental professionals in their review and interpretation of CBCT images by facilitating anatomical assessment and supporting their diagnostic and treatment planning process.
The product uses AI to automatically identify, label, segment, and quantify key anatomical and restorative structures in CBCT scans, surfacing clinically relevant measurements such as periodontal bone levels, airway minimal cross-sectional area, tooth-to-maxillary sinus and tooth-to-inferior alveolar canal distances, and tooth impaction ratio (percent of crown within bone).
“This FDA clearance for CBCT Assist, Overjet’s 10th FDA clearance to date, is a critical milestone that reinforces our leadership in bringing clinically validated AI to the forefront of oral healthcare,” said Dr. Wardah Inam, CEO of Overjet. “As the industry standard for dental AI, we are committed to giving providers the best tools available to drive evidence-based treatment and ensure the highest quality of care for their patients.”
The CBCT Assist platform combines essential image enhancement tools such as brightness, contrast, and Virtual Panoramic reconstruction, with measurement capabilities for distance, area, angle, and signal intensity.
Key clinical capabilities include:
- Advanced Visualization: features Multi-Planar Reconstruction (MPR) views and 3D Volume Rendering for a thorough view of patient anatomy.
- Surgical Planning & Safety: Facilitates third molar surgery planning by generating linear measurement to nearby critical structures.
- Implant Site Evaluation: Provides robust measurement tools to support assessment of bone availability and anatomy for optimal implant placement.
- Airway Assessment: Supports airway evaluation by automatically reporting the minimum cross-sectional area.
Dr. Parag Kachalia, Head of Clinical Practice at Overjet, said, “The FDA clearance for CBCT Assist is more than just a regulatory achievement; it is validation of our foundational scientific rigor. This innovation directly supports our mission to provide unparalleled diagnostic clarity and elevate the quality of care across the entire dental ecosystem.”
Clinics based in the US can sign up for early access to Overjet’s CBCT Assist.
Overjet is the world leader in dental AI. Founded by experts from MIT and Harvard University, Overjet builds artificial intelligence that helps dental organizations give patients the highest quality of care. Its technology is FDA-cleared to detect, outline, and quantify major oral health conditions, enabling dentists to diagnose with precision and educate patients with confidence. To learn more, visit overjet.com.
