FDA Clears AI Software That Reads 3D Dental Scans in Real Time

In late July 2026, the U.S. Food and Drug Administration granted 510(k) clearance to VELMENI for its V4D 3D software, an artificial intelligence tool designed to help dental professionals review cone-beam computed tomography (CBCT) scans. CBCT imaging produces detailed three-dimensional views of the jaw, teeth, and surrounding structures — information that has long been essential for implant planning, root canal assessment, orthodontic evaluation, and airway analysis.

The software works by automatically identifying and labeling anatomical structures within a CBCT scan, including the upper and lower jaws, individual teeth, the mandibular canal, the maxillary sinuses, the jaw joints, and the airway. It can also generate reconstructed panoramic views from the 3D dataset, which may streamline how clinicians review and share findings. The FDA clearance applies to scans of patients aged 15 and older who have permanent teeth.

Importantly, the tool is described as a support aid rather than a replacement for clinical judgment. The software provides information to assist licensed dental professionals, who remain fully responsible for examination, diagnosis, and treatment decisions. VELMENI tested the software's segmentation and labeling performance on 127 de-identified images from four U.S. dental offices before submitting for clearance.

This clearance is part of a broader trend: several dental AI platforms have now received FDA authorization for 3D imaging analysis over the past few years, reflecting growing regulatory and clinical interest in bringing artificial intelligence into everyday dental workflows. For patients, this type of technology may eventually mean faster scan review, clearer visual explanations of findings, and more consistent interpretation of complex imaging studies.