VELMENI Receives FDA 510(k) Clearance for 3D CBCT Dental Imaging Software

Posted: July 24, 2026
Edited by Dentaltown staff

SUNNYVALE, Calif.—VELMENI has received 510(k) clearance from the U.S. Food and Drug Administration for VELMENI for DENTISTS (V4D) 3D, artificial intelligence software for reviewing dental cone-beam computed tomography scans.

The software is designed to assist dental professionals in analyzing CBCT scans through AI-assisted anatomical segmentation, visualization, measurements, and image reconstruction, the company said.

According to VELMENI, it identifies, labels, and segments structures such as the maxilla, mandible, mandibular canal, teeth, maxillary sinuses, temporomandibular joints, and airway. It also generates reconstructed panoramic and cross-sectional views, provides measurements, and exports STL files for patient education and laboratory collaboration.

“Our 3D AI helps clinicians review complex CBCT scans more efficiently, supporting confident decisions while streamlining the clinical workflow,” said Mini Suri, CEO and co-founder of VELMENI.

The product joins VELMENI ONE, the company’s platform combining 2D radiograph analysis, voice-enabled periodontal charting, CBCT reporting, and claims automation. It is intended for general dentists, specialists, dental service organizations, and imaging centers. VELMENI said the software does not replace a clinical examination or professional judgment.

For more information, visit velmeni.ai.
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