FDA Clears AI Software That Helps Dentists Read 3D Jaw Scans More Easily

On July 23, 2026, the U.S. Food and Drug Administration granted 510(k) clearance to a California-based dental AI company called VELMENI for its three-dimensional imaging software, known as V4D 3D. The tool is designed to help dental professionals work with cone-beam computed tomography scans — a type of 3D X-ray that produces far more detail than a standard dental radiograph but can be time-consuming and complex to interpret.

The software uses artificial intelligence to automatically identify and label structures inside a CBCT scan, including the upper and lower jaws, the nerve canal that runs through the lower jaw, individual teeth, the maxillary sinuses, the jaw joints, and the airway. Those structures can then be viewed in three dimensions to help clinicians review anatomy, plan treatments, and communicate findings to patients or other specialists. The system can also automatically reconstruct the kind of panoramic and cross-sectional views that dentists use routinely, pulling them directly from the 3D data rather than requiring a separate scan.

The clearance matters for patients because CBCT imaging is increasingly used before implant placement, oral surgery, root canal procedures, and orthodontic planning — cases where a small anatomical detail, such as the exact position of a nerve, can significantly affect how a procedure is carried out. By making it faster and more consistent to map those details, AI-assisted tools like this one could reduce the chance that something important is missed in a complex case.

VELMENI and the FDA have both emphasized that the software is intended to support trained dental professionals, not replace their judgment. Final diagnoses and treatment decisions remain the clinician's responsibility. The clearance represents a regulatory milestone, however, confirming that an independent review found the tool met safety and performance standards for use in actual clinical practice.