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AI Software Clears FDA for Dental Scans
24 Jul
Summary
- V4D 3D software uses AI for complex dental CBCT scans.
- FDA 510(k) clearance enables broader use in dentistry.
- The tool aids interpretation, not replaces professional judgment.

Dental AI company Velmeni recently secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Velmeni for Dentists (V4D) 3D software. This AI-driven system applies advanced algorithms to three-dimensional cone-beam computed tomography (CBCT) scans, enhancing Velmeni's existing suite of dental imaging tools.
The V4D 3D software is designed to assist qualified dental professionals in analyzing CBCT scans. It provides AI-assisted anatomical segmentation, sophisticated 3D visualizations, precise measurement capabilities, and high-resolution image reconstruction.
This clearance marks a significant advancement in dental diagnostics, offering specialists like endodontists, orthodontists, and oral surgeons tools for more efficient and accurate interpretation of complex dental data. The software supports standard tessellation language (STL) file export for creating 3D models, aiding in education and collaboration.
Velmeni stresses that V4D 3D is a supportive tool, intended to augment rather than replace a comprehensive clinical examination or professional judgment. The ultimate responsibility for patient diagnoses and treatment decisions remains with the treating dental professional. The software is now integrated into the Velmeni One platform.