Orca Dental AI has gained FDA clearance for its CephX 3D imaging platform and announced new integrations with DEXIS and Greyfinch software.
Orca Dental AI announced that its CephX platform has received FDA clearance for 3D imaging. The company also revealed new integrations with DEXIS and Greyfinch to embed its AI-powered cephalometric analysis into their respective platforms.
With the new regulatory approval, CephX now has FDA clearance for both 2D and 3D imaging analysis.
FDA Clearance for 3D Imaging
The class II 510(k) clearance for CEPHX3D allows clinicians to use AI-powered 3D analysis tools within their imaging workflows. The platform includes linear, angular, and volumetric measurement tools for anatomical analysis, maxillofacial visualization, and CBCT cross-section reports.
According to the company, the clearance supports clinicians with deeper insight into patient anatomy and treatment planning.
New Platform Integrations
CephX has integrated its AI-powered cephalometric analysis into the DTX Studio Clinic by DEXIS. The integration allows clinicians to generate automated tracings and analyses within the imaging workflow, which is intended to accelerate treatment planning.
“The integration of CephX and DTX Studio Clinic reinforces our commitment to delivering connected, AI-powered workflows that elevate diagnostic precision and clinical efficiency,” says Robert Befidi, president of DEXIS, in a release. “By embedding advanced cephalometric automation directly into our platform, we are empowering orthodontic providers with faster insights and greater consistency across every clinic.”
The platform is also now integrated into Greyfinch’s cloud-based orthodontic practice management software. Within the Greyfinch platform, users can upload 2D cephalometric images or 3D CBCT scans and receive AI-generated analyses in seconds.
“Our goal at Greyfinch is to simplify the operational and clinical workflow for orthodontic practices,” says Jake Gulick, president of Greyfinch, in a release. “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.”
The company’s goal is to create a connected ecosystem for diagnostic support.
“Our mission has always been to bring AI exactly where clinicians work—without adding friction,” says Daniel Abraham, chief executive officer and founder of Orca Dental AI, in a release. “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.”
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