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

Tech

VELMENI AIJuly 23, 2026

VELMENI for DENTISTS® 3D brings AI-assisted CBCT segmentation, anatomical visualization, measurements, panoramic reconstruction, and workflow support to dental practices, specialists, DSOs, and imaging centers.

SUNNYVALE, Calif., July 23, 2026 /PRNewswire/ — VELMENI, a dental artificial intelligence company developing connected clinical and administrative workflows for dentistry, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for VELMENI for DENTISTS (V4D) 3D.

The FDA clearance, issued under 510(k), expands VELMENI’s dental AI portfolio into three-dimensional cone-beam computed tomography, or CBCT, imaging. VELMENI for DENTISTS (V4D) 3D is designed to assist qualified dental professionals in reviewing and analyzing dental CBCT scans through AI-assisted anatomical segmentation, visualization, measurements, and image reconstruction.

By bringing 2D dental radiograph analysis and 3D CBCT intelligence into the broader VELMENI platform, the company is building a more connected dental AI workflow for general dentists, oral and maxillofacial radiologists, oral surgeons, orthodontists, prosthodontists, endodontists, dental service organizations, and imaging centers.

“VELMENI’s vision extends beyond isolated AI image interpretation,” said Mini Suri, CEO and Co-Founder of VELMENI. “Our 3D AI helps clinicians review complex CBCT scans more efficiently, supporting confident decisions while streamlining the clinical workflow.”

AI-Assisted 3D CBCT Review for Modern Dental Workflows

Dental CBCT imaging provides detailed three-dimensional views of oral and maxillofacial anatomy that can support implant planning, endodontic assessment, orthodontic evaluation, surgical review, airway analysis, and other dental applications.

VELMENI for DENTISTS (V4D) 3D applies artificial intelligence to help dental professionals navigate complex CBCT datasets and convert volumetric imaging information into clear, clinically useful visualizations.

Subject to the product’s FDA-cleared indications for use, key capabilities include:

Intelligent 3D Anatomical Segmentation
VELMENI’s 3D dental AI assists with identifying, labeling, and segmenting anatomical structures such as the maxilla, mandible, mandibular canal, teeth, maxillary sinuses, temporomandibular joints, and airway structures. These segmented structures can be viewed in three dimensions to support anatomical review, treatment planning, specialist collaboration, and patient education.
Automated Panoramic Reconstruction and Cross-Sectional Views
The software automatically identifies the dental arch and generates reconstructed panoramic and cross-sectional views from CBCT datasets, enabling efficient review of anatomical structures across multiple planes.
Measurements and Multi-Dimensional Visualization
VELMENI for DENTISTS (V4D) 3D provides clinically relevant measurements and high-resolution multi-planar and three-dimensional visualizations to support efficient CBCT review and treatment-planning workflows.
STL Export for Education and Collaboration
Users can export detailed STL files to create three-dimensional models for patient education, case presentation, and collaboration with specialists and dental laboratories.
Structured Reporting and Workflow Connectivity
VELMENI’s platform connects CBCT imaging insights with structured reporting, clinical documentation, and collaborative workflows, helping practices streamline imaging, documentation, and patient communication.

Supporting Clinicians—Not Replacing Clinical Judgment

VELMENI for DENTISTS 3D is intended to assist qualified dental professionals and is not a replacement for a complete clinical examination, professional judgment, patient history, or in-person assessment. Final diagnoses, treatment recommendations, and patient treatment plans remain the responsibility of the treating dental professional.

“As an oral and maxillofacial radiologist, I have seen how responsibly developed artificial intelligence can improve consistency and efficiency in dental imaging review while supporting clinical decision-making,” said Dr. Dale Miles, DDS, MS, FRCD(C), Oral and Maxillofacial Radiologist, DoctorConeBeam, and CBCT Advisor to VELMENI.

“VELMENI brings together three important AI-native workflows—voice, two-dimensional imaging, and three-dimensional imaging—within one connected platform,” said Dr. Nodesh Shyamsunder, Oral and Maxillofacial Prosthodontist. “The system is intuitive, and the reduction in repetitive workload can be immediate.”

Expanding the VELMENI ONE Dental AI Platform

VELMENI for DENTISTS (V4D) 3D is part of VELMENI ONE, a connected dental AI platform that brings together:

AI-assisted 2D dental X-ray analysis
AI-powered 3D CBCT imaging and visualization
Voice-enabled periodontal charting and clinical documentation
Automated CBCT reporting support
Dental insurance claims automation
Clinical workflow and practice-management integrations

Unlike standalone dental imaging applications, VELMENI ONE is designed to connect clinical imaging, documentation, patient communication, and administrative workflows within one intelligent dental AI ecosystem.

About VELMENI

VELMENI is an AI-powered dental technology company transforming clinical workflows through intelligent imaging and automation. VELMENI ONE unifies AI-powered 2D imaging, 3D CBCT analysis, voice-enabled clinical documentation, structured reporting, and workflow automation into a single connected platform. Designed for dental practices, specialists, DSOs, and imaging centers.

To learn more about VELMENI dental AI or schedule a personalized demonstration, visit velmeni.ai.

Regulatory Notice

VELMENI products are intended to assist qualified dental professionals and are not substitutes for professional judgment or a complete clinical examination. Final diagnoses and treatment plans remain the responsibility of the treating dental professional. Product availability and regulatory status vary by market.