Sunnyvale, California-based dental AI firm VELMENI announced on July 23, 2026, that the U.S. FDA has granted 510(k) clearance for its latest software, VELMENI for DENTISTS (V4D) 3D. The approval extends the company’s existing 2D imaging technology into three-dimensional cone-beam CT (CBCT) analysis, giving dental professionals a broader AI-driven toolkit for scan interpretation.
The new system helps clinicians segment anatomical structures, generate panoramic and cross-sectional reconstructions, take precise measurements, and produce exportable 3D models — features aimed at supporting implant planning, orthodontics, surgery, and airway evaluation. It’s built for general dentists, specialists, dental service organizations, and imaging centersalike.
Company leadership described the release as part of a broader push toward unifying dental workflows rather than offering isolated imaging tools. Independent experts consulted by the company noted the software could improve efficiency without replacing clinical judgment, which remains with the treating practitioner.
The tool is now part of VELMENI ONE, the company’s integrated dental AI platform spanning imaging, documentation, and administrative automation.
Written By: Sayan Das
Graphics by: Pramit Hazra
