Orca Dental AI announced that its CephX platform has received FDA clearance for 3D imaging, adding to its existing 2D capabilities. According to the company, the clearance marks an expansion of AI-powered diagnostic support within orthodontic imaging workflows.
The company stated that the newly cleared CEPHX3D (class II 510k) enables clinicians to use AI-driven 3D analysis in orthodontic imaging. According to the company, the system includes CBCT segmentation of the mandible, maxilla, dentition, and inferior alveolar nerve; an interactive web-based STL and DICOM viewer for visualization of airway and maxillofacial structures; and tools for linear, angular, and volumetric measurements, along with image reporting and cross-section analysis. The company indicated that these capabilities are intended to support treatment planning and provide additional insight into patient anatomy and anomalies.
Alongside the FDA clearance, Orca Dental AI reported expanded integrations with DEXIS and Greyfinch. According to the company, these integrations are designed to incorporate AI-driven cephalometric analysis into imaging and practice management systems, supporting clinical workflows and diagnostic processes.
“Our mission has always been to bring AI exactly where clinicians work — without adding friction,” said Daniel Abraham, CEO and 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.”
Through integration with DTX Studio Clinic by DEXIS, CephX enables clinicians to generate automated tracings and analyses within the imaging workflow. According to the company, this includes cephalometric tracing and superimpositions, VTO/STO planning support, reporting, cloud-based record management, and tools to support multi-location practices and DSOs.
“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 has also been integrated into Greyfinch’s cloud-based orthodontic practice management platform. According to the company, clinicians can upload 2D cephalometric images or 3D CBCT scans and receive AI-generated analyses within seconds. The platform converts 3D DICOM files into calibrated 2D radiographs, identifies anatomical landmarks, generates analyses, and incorporates results into patient records.
“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.”
Additional features within the Greyfinch integration include CBCT and IOS segmentation into 3D STL models, IOS stitching and meshing, AI-generated root movement visualization, a web-based viewer with measurement and collaboration tools, and diagnostic functions such as airway analysis, cross-section reports, nerve alerts, crossbite analysis, bone anchorage reporting, and panoramic image generation.
Founded in 2015, Orca Dental AI develops AI-based diagnostic and treatment planning tools for orthodontics and dental care. According to the company, its cloud-based platform integrates with imaging and practice management systems to support clinical workflows. More information is available at www.cephx.com.
