DOVER, Del., March 24, 2026 /CNW/ -- Orca Dental AI, the global leader in AI-powered orthodontic imaging solutions and creator of the CephX platform, today announced it has received FDA clearance for 3D imaging, marking a major milestone in the company's mission to bring advanced AI-powered diagnostic support into everyday clinical workflows.

With this additional regulatory approval, CephX becomes the only orthodontic AI diagnostic support company with FDA clearance for both 2D and 3D imaging.

Alongside this regulatory milestone, Orca Dental AI also announced expanded strategic integrations with DEXIS™ and Greyfinch, further embedding CephX's AI-driven cephalometric analysis into leading imaging and practice management ecosystems worldwide.

Together, these developments strengthen CephX's position as a connected AI diagnostic platform designed to support orthodontists and dental specialists with faster analysis, improved visualization, and more efficient clinical workflows.

CEPHX Receives FDA Clearance for 3D Imaging

Orca Dental AI also announced that CEPHX3D has received FDA clearance (class II 510k), enabling clinicians to leverage advanced AI-powered 3D analysis within orthodontic imaging workflows.

CEPHX3D includes:

• AI CBCT segmentation of the mandible, maxilla, full dentition (crowns and roots), and the inferior alveolar nerve (IAN)
• An interactive web-based 3D STL & DICOM viewer allowing better visualization and understanding of patient anatomy, including the airway and maxillofacial structures, for clinical and educational purposes.

       • Linear, angular, and volumetric measurement tools for anatomical analysis

     -  Maxillofacial Visualization
     -  Advanced Image Reporting & Insights     
     -  CBCT Cross-Section Reports

This clearance further strengthens CephX's ability to deliver intelligent, AI-driven diagnostic tools that support clinicians with deeper insight into patient anatomy, anomalies  and treatment planning.

Building the Connected AI Diagnostic Ecosystem

With integrations spanning imaging leaders like DEXIS and practice management platforms like Greyfinch, CephX continues to expand as a fully embedded AI engine across the orthodontic diagnostic journey.

"Our mission has always been to bring AI exactly where clinicians work — without adding friction," said Daniel Abraham, CEO & Founder of Orca Dental AI. "By integrating CephX into both imaging and practice management platforms, we're creating a connected ecosystem that saves time, improves accuracy, and empowers clinicians to focus on patient care."

Trusted by thousands of orthodontists and DSOs across more than 180 countries, CephX's FDA-cleared, HIPAA-compliant SaaS platform delivers automated cephalometric analysis, advanced 3D tools for CBCT imaging, and predictive diagnostic insights powered by a proprietary, extensive and diverse dataset

As digital dentistry continues to evolve, CephX remains committed to enabling scalable, intelligent workflows that improve clinical outcomes and operational efficiency worldwide.

CephX Now Integrated into DTX Studio™ Clinic by DEXIS

Through its integration with DTX Studio™ Clinic by DEXIS, CephX delivers AI-powered cephalometric analysis directly within the imaging workflow. Clinicians can generate automated tracings and analyses within seconds, accelerating treatment planning while maintaining clinical precision.

Key benefits include:

• AI-driven cephalometric tracing and superimpositions
• VTO/STO planning support
• Immediate reporting and reduced turnaround time
• Secure, cloud-based record management
• Scalable deployment for multi-location practices and DSOs
• Enhanced patient communication through clear visual analyses

This collaboration advances the DEXIS platform strategy and establishes CephX as the core AI intelligence layer powering modern orthodontic imaging.

"The integration of CephX and DTX Studio Clinic reinforces our commitment to delivering connected, AI-powered workflows that elevate diagnostic precision and clinical efficiency," said Robert Befidi, President of DEXIS. "By embedding advanced cephalometric automation directly into our platform, we are empowering orthodontic providers with faster insights and greater consistency across every clinic."

CephX Embedded into Greyfinch Cloud-Based Practice Management

CephX is now fully integrated into Greyfinch's cloud-based orthodontic practice management platform, bringing AI-powered diagnostic automation directly into the clinical and operational workflow.

Within Greyfinch, clinicians can upload 2D cephalometric images or 3D CBCT scans and receive complete AI-generated cephalometric analyses within seconds.

CephX automatically:

• Converts 3D DICOM files into calibrated 2D radiographs
• Identifies and validates anatomical landmarks
• Generates ready-to-use cephalometric analyses
• Streamlines diagnostic documentation within the patient record

Beyond cephalometric analysis, CephX also enables advanced AI-powered 3D diagnostic tools, including:

• Automated CBCT and IOS segmentation into clean 3D STL models
• IOS stitching and meshing to visualize crown and root anatomy
• Smart Roots technology for AI-generated root movement visualization
• A web-based DICOM/STL viewer with measurement, annotation, and collaboration tools
• Airway visualization and analysis with volume and cross-sectional views
• Additional AI-powered diagnostics including cross-section reports, nerve alerts, crossbite analysis, bone anchorage reports, and panoramic image generation

Together, these capabilities streamline radiographic workflows, reduce operational strain, and improve diagnostic consistency across single clinics and multi-location dental organizations.

"Our goal at Greyfinch is to simplify the operational and clinical workflow for orthodontic practices," said Jake Gulick, President of Greyfinch. "Integrating CephX allows our users to access advanced AI-powered cephalometric analysis without leaving the platform, saving time and improving the efficiency of treatment planning."

About Orca Dental AI (CephX)

Orca Dental AI is a global leader in AI-powered dental diagnostics and treatment planning. Founded in 2015, Orca transformed orthodontic care through CephX.com - one of the first platforms to automate imaging workflows and cephalometric analysis using machine learning.

Its FDA-cleared, cloud-based platform integrates seamlessly with leading imaging and practice management systems, delivering high-accuracy diagnostic support across orthodontics and broader dental care.

Learn more at:
www.cephx.com

Logo: https://mma.prnewswire.com/media/2941025/Orca_FDA_3D_Logo.jpg

Media Contact:
Michal Minitzer
Marketing Manager
michal@cephx.com

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SOURCE Orca Dental AI