Orca Dental AI Receives New FDA Clearance, Making CephX the Only 2D+3D FDA-Cleared Orthodontic AI Diagnostic Platform

Image source: Orca Dental AI official website

DentalGoodNews | March 24, 2026 - Orthodontic AI imaging solutions provider Orca Dental AI announced that its CephX platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for 3D imaging. Orca Dental AI stated that with this approval, the company has become the only orthodontic AI diagnostic support company currently holding both 2D and 3D imaging FDA certifications.

According to the official announcement, the newly approved CEPHX3D system provides clinicians with AI-driven 3D analysis capabilities. The system supports AI-powered automatic segmentation of the mandible, maxilla, full dentition (including crowns and roots), and the inferior alveolar nerve (IAN) from Cone Beam Computed Tomography (CBCT) scans. Additionally, the platform is equipped with a web-based interactive 3D STL and DICOM viewer, supporting linear, angular, and volumetric measurements, which can effectively enhance doctors' ability to visualize patient anatomy and airway conditions.

Alongside this regulatory milestone, Orca Dental AI also announced a deepened strategic integration with the DEXIS brand and the clinic management platform Greyfinch, both under Envista. By integrating with the DTX Studio Digital Ecosystem Clinic platform from DEXIS, CephX can provide AI-driven cephalometric analysis directly within the imaging workflow, helping doctors complete automated tracing and analysis in seconds, thereby accelerating treatment plan formulation. Robert Befidi, President of DEXIS, stated that this integration further strengthens the company's commitment to providing connected AI workflows.

The integration with Greyfinch introduces AI diagnostic automation directly into the clinic's operational workflow. Clinicians can upload 2D or 3D images on the platform, and CephX will automatically convert 3D DICOM files into calibrated 2D radiographs, identify anatomical landmarks, and enable seamless archiving of diagnostic documents. Jake Gulick, President of Greyfinch, pointed out that this move aims to streamline operations in orthodontic clinics and improve the overall efficiency of treatment planning.

According to information on its official website, Orca Dental AI was founded in 2015, and its CephX platform is currently used in over 180 countries.