FDA-cleared AI cephalometric analysis for orthodontic and dental imaging
Orca Dental AI by Orca Dental AI Ltd · Wilmington, DE
AI cephalometric analysis and CBCT segmentation for orthodontic and dental imaging workflows.
Orca Dental AI’s CephX platform automates cephalometric analysis using AI-driven landmark detection on lateral cephalometric radiographs. The system identifies anatomical landmarks, computes angular and linear measurements, and supports hundreds of analysis configurations, replacing the manual tracing process that orthodontists and general dentists traditionally perform by hand or with semi-automated software.
The FDA cleared CephX for cephalometric analysis (K231396, January 2024). The clearance specifies that results are dependent on interpretation by trained and licensed practitioners, and the device is approved for patients 14 years and older. Beyond 2D cephalometrics, the platform also provides CBCT segmentation and a 3D-to-2D conversion feature that generates a lateral cephalometric view from a CBCT scan, potentially eliminating the need for a separate cephalometric x-ray exposure.
Where Orca Dental AI fits in the market: Unlike Overjet, Pearl, and VideaHealth (which focus on detecting caries, bone loss, and other pathologies on bitewing and periapical radiographs), Orca Dental AI is specialized for the orthodontic imaging workflow. Practices that rely on cephalometric analysis for treatment planning are the primary audience. For general pathology detection, you will still need one of the broader diagnostic AI platforms. Orca Dental AI partnered with Planmeca to bring its segmentation capabilities to Planmeca’s imaging ecosystem, and separately partnered with West Coast Dental to deploy the platform across a multi-location DSO.
+ Strengths
- One of the few FDA-cleared AI platforms specifically focused on cephalometric analysis
- 3D-to-2D conversion feature reduces patient radiation by eliminating the need for separate lateral ceph exposures
- Cloud delivery and free trial lower the evaluation barrier for practices
− Limitations
- No bitewing or periapical pathology detection. You still need a separate tool (Overjet, Pearl, or VideaHealth) for caries and bone loss screening
- Narrower PMS integration footprint than competitors with confirmed Dentrix, Eaglesoft, and Open Dental support
Key Use Cases
Automated cephalometric tracing and measurement for orthodontic treatment planning
CBCT volume segmentation for implant and surgical workflows
Multi-location DSO standardization of cephalometric analysis
Verdict
Orca Dental AI fills a specific niche: AI-automated cephalometric analysis and CBCT segmentation. If your practice does significant orthodontic work and wants to automate ceph tracing, it is worth evaluating alongside Diagnocat (which also offers CBCT analysis). It does not replace general-purpose dental AI tools like Overjet, Pearl, or VideaHealth for caries and pathology detection on intraoral radiographs. Think of it as a complementary tool for the orthodontic imaging workflow.