Orthodontic AI company earns FDA approval for 3D imaging

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Dover, Del.-based Orca Dental AI, an AI-powered orthodontic imaging company, has received FDA clearance for 3D imaging. 

With the approval, the company’s CephX platform is the only orthodontic AI diagnostic support platform with FDA clearance for both 2D and 3D imaging, according to a March 24 news release from Orca Dental AI. 

The platform includes AI CBCT segmentation of mandible, maxilla, full dentition and the inferior alveolar nerve, along with linear, angular and volumetric measurement tools for analysis. 

CephX is utilized by orthodontists and DSOs in more than 180 counties, the release said.

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