- What it does: Orca Dental AI's CephX platform automates cephalometric analysis using AI landmark detection on lateral cephalometric radiographs, with CBCT segmentation and a 3D-to-2D conversion feature. It is FDA-cleared under K231396 and is specialized for orthodontic imaging workflows rather than general pathology detection.
- Regulatory: 2 FDA 510(k) clearances (K252538, K231396)
- Pricing: Not published (Contact sales)
- Best fit: ortho, specialist
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.
Orca Dental AI vs alternatives
Other imaging & diagnostics tools we track: Overjet (quote only, 12 FDA clearances), Pearl (quote only, 8 FDA clearances), Dentsply Sirona DS Core (quote only, 4 FDA clearances), Velmeni (quote only, 4 FDA clearances).
Is Orca Dental AI FDA cleared?
Yes. Orca Dental AI holds 2 FDA 510(k) clearances: K252538 (Mar 5, 2026) for cephX3D: analysis of dental and craniomaxillofacial images (including 3D) to support diagnosis and treatment planning, for patients 12 and older.; K231396 (Jan 31, 2024) for cephX: cephalometric analysis, simulation, profilogram and VTO for orthodontic treatment, patients 14 and older.. Features outside those indications are not covered by the clearance.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K252538 | CEPHX3D | Mar 5, 2026 | CephX3D: analysis of dental and craniomaxillofacial images (including 3D) to support diagnosis and treatment planning, for patients 12 and older. |
| K231396 | CEPHX- Cephalometric Analysis Software | Jan 31, 2024 | CephX: cephalometric analysis, simulation, profilogram and VTO for orthodontic treatment, patients 14 and older. |
What Orca Dental AI does
Imaging modalities: lateral cephalometric, CBCT.
- AI landmark detection for cephalometric analysis
- CBCT segmentation
- 3D-to-2D conversion of CBCT to a lateral cephalometric view
How much does Orca Dental AI cost?
Orca Dental AI does not publish pricing; it is quoted by sales (Contact sales). Pricing is not published; contact the vendor.
- 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
- 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
Where it fits
- Automated cephalometric tracing and measurement for orthodontic treatment planning
- CBCT volume segmentation for implant and surgical workflows
- Multi-location DSO standardization of cephalometric analysis
Common questions
What does Orca Dental AI integrate with?
Orca Dental AI lists integrations with Planmeca. Confirm compatibility with your exact practice management and imaging versions before signing.
Sources
Corrections and updates
- 2026-10-21: Clearance list synced with the FDA 510(k) database: now 2 clearance(s). Added K252538.