Other
CephX3D
Orca Dental AI, Ltd.
FDA
FDA-cleared AI medical device
Web-based software that analyzes dental CBCT scans with AI-driven segmentation of the mandible, maxilla, dentition, and inferior alveolar nerve, providing three-dimensional visualization and measurement tools to support orthodontic and dental imaging workflows.
FDA Submission Metadata
- Submission number
- K252538
- Decision date
- March 2026
- FDA panel
- Radiology
- Product code
- QIH
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA