AI dental company announces 510(k) clearance from the U.S. Food and Drug Administration for Overjet CBCT Assist.
By Dentistry Today Staff
AI company Overjet 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.
With this new clearance, Overjet’s clinical intelligence platform extends its AI capabilities to CBCT imaging, further solidifying its position as a leading comprehensive clinical intelligence AI solution in dentistry. 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 algorithms to automatically identify, label, segment, and measure anatomical and restorative structures—including mesial, distal, buccal, lingual bone levels, minimum airway cross section areas, tooth to maxillary sinus cavity or inferior alveolar canal distance, bone height at potential implant sites, and impaction ratio in 3D scans.
“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 Overjet CEO Dr. Wardah Inam, in today’s press release. “As the industry standard for dental AI, we are committed to providing providers with the most precise 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 Health Assessment: Supports airway evaluation by automatically reporting the minimum cross-sectional area.
Parag Kachalia, DDS, head of clinical practice at Overjet, added, “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 by clicking here, or for more information, visit overjet.com.
