Overjet announced it has received 510(k) clearance from the U.S. Food and Drug Administration for Overjet CBCT Assist. The clearance allows the company to extend its artificial intelligence platform to support interactive review and diagnostic interpretation of three-dimensional cone beam computed tomography imaging.
According to the company, the clearance expands Overjet’s clinical intelligence platform to include CBCT imaging, enabling dental professionals to review and interpret scans through anatomical assessment and diagnostic and treatment planning support.
Overjet CBCT Assist uses artificial intelligence to automatically identify, label, segment, and quantify anatomical and restorative structures within CBCT scans, according to the company. The software surfaces measurements including periodontal bone levels, airway minimal cross-sectional area, tooth-to-maxillary sinus distance, tooth-to-inferior alveolar canal distance, and tooth impaction ratio expressed as the percentage 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.”
According to the company, the CBCT Assist platform combines image enhancement tools such as brightness adjustment, contrast control, and virtual panoramic reconstruction with measurement functions for distance, area, angle, and signal intensity.
The platform includes visualization capabilities using multi-planar reconstruction views and three-dimensional volume rendering; tools intended to support third molar surgical planning through linear measurements to nearby anatomical structures; measurement features designed to assist in evaluating bone availability and anatomy for implant planning; and automated reporting of minimum cross-sectional area for airway assessment, according to the company.
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.”
According to the company, clinics based in the United States are able to sign up for early access to Overjet’s CBCT Assist at info.overjet.com/marketing/cbct-launch.
