Orca Dental AI vs Pearl
Orca Dental AI is for orthodontic imaging: CephX is cleared for cephalometric analysis (K231396) and CephX3D for 3D craniomaxillofacial analysis from age 12 (K252538). Pearl is for general-dentistry x-rays: its core clearance (K210365) covers caries, calculus and periapical findings on bitewings and periapicals, and others add bone level, panoramics, children and CBCT anatomy. An ortho practice that also screens for decay could use both.
Orca Dental AI or Pearl: which should you choose?
- You are an orthodontist who wants AI landmarking, ceph measurements, simulation and VTO (K231396)
- You want 3D craniomaxillofacial analysis for treatment planning from age 12 (CephX3D, K252538)
- You want to try it before talking to sales: CephX offers a 7-day or 3-case free trial
- You want general-dentistry screening on bitewings and periapicals, plus pediatric caries from age 4 (K243893)
- You want CBCT anatomy marked, including the inferior alveolar canal, sinus and airway (K243989)
- You want practice-level metrics through Pearl's Practice Intelligence module
What is each FDA-cleared for?
| Cleared for | Orca Dental AI | Pearl |
|---|---|---|
| Caries | No | Yes (K250525, K243234, K243893, K242522, K210365) |
| Bone level | No | Yes (K243230) |
| Calculus | No | Yes (K210365) |
| Periapical radiolucency | No | Yes (K250525, K242600, K210365) |
| CBCT anatomy, segmentation or viewing | No | Yes (K243989) |
| Findings or charting on panoramic x-rays | No | Yes (K250525) |
| Children | No | Yes (K243893) |
| Cephalometric analysis | Yes (K252538, K231396) | No |
| Treatment planning & design | Yes (K252538, K231396) | No |
From each clearance's indications for use in the FDA 510(k) database. Full list: FDA-cleared dental AI companies.
Orca Dental AI vs Pearl: FDA clearances, price and integrations side by side
| Orca Dental AI | Pearl | |
|---|---|---|
| Vendor | Orca Dental AI Ltd · Wilmington, DE | Pearl Inc. · Los Angeles, CA |
| Category | Imaging & diagnostics | Imaging & diagnostics |
| FDA 510(k) | K252538 (Mar 5, 2026); K231396 (Jan 31, 2024) | K250525 (Nov 14, 2025); K243234 (Jun 12, 2025); K243989 (May 23, 2025); K243230 (May 9, 2025); K243893 (May 5, 2025); K242600 (Apr 11, 2025); K242522 (Jan 16, 2025); K210365 (Mar 4, 2022) |
| Cleared for | CephX3D: analysis of dental and craniomaxillofacial images (including 3D) to support diagnosis and treatment planning, for patients 12 and older. / CephX: cephalometric analysis, simulation, profilogram and VTO for orthodontic treatment, patients 14 and older. | Marks suspected caries, periapical radiolucency and impacted third molars on panoramic radiographs, patients 16 and older. / Second Opinion CS: detection and segmentation of caries on periapical radiographs, permanent teeth, patients 12 and older (second reader). / Second Opinion 3D: marks anatomy on CBCT (dentition, maxilla, mandible, inferior alveolar canal, sinus, airway). / Second Opinion BLE: bone-level measurements on bitewing and periapical radiographs, patients 12 and older. / Second Opinion Pediatric: caries detection on bitewing and periapical radiographs, patients 4 and older (primary or mixed dentition). / Periapical radiolucency detection with outlined regions on periapical radiographs, permanent teeth, patients 12 and older (second reader). / Second Opinion CC: caries detection with outlined regions on bitewing and periapical radiographs, patients 19 and older (second reader). / Second Opinion: detection of caries, calculus, periapical radiolucency and other findings on bitewing and periapical radiographs. |
| Imaging modalities | lateral cephalometric, CBCT | bitewing, periapical, panoramic, CBCT |
| Pricing | From $69/mo (per month, by plan and cases per month; $79/mo month to month) | Not published (contact sales) |
| Integrations | Planmeca | Eaglesoft, Dentrix, Open Dental, Curve Dental, Carestack |
| Best fit | ortho, specialist | group, dso |
| Last verified | Nov 2, 2026 | Oct 22, 2026 |
From each vendor's site and the FDA 510(k) database. Orca Dental AI price: cephx.com.
Strengths and limits
- 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
- Caries, calculus, periapical and restoration findings in a single clearance (K210365)
- Widest PMS integration coverage, working with 5+ major systems
- Practice Intelligence adds business analytics on top of clinical detection
- Enterprise pricing model; cost unclear until sales conversation
- Detection accuracy is condition-dependent, strongest on caries, weaker on marginal bone loss
Next steps
Common questions
What is the difference between Orca Dental AI and Pearl?
Orca Dental AI is for orthodontic imaging: CephX is cleared for cephalometric analysis (K231396) and CephX3D for 3D craniomaxillofacial analysis from age 12 (K252538). Pearl is for general-dentistry x-rays: its core clearance (K210365) covers caries, calculus and periapical findings on bitewings and periapicals, and others add bone level, panoramics, children and CBCT anatomy. An ortho practice that also screens for decay could use both.
Which is FDA cleared, Orca Dental AI or Pearl?
Orca Dental AI: K252538, K231396. Pearl: K250525, K243234, K243989, K243230, K243893, K242600, K242522, K210365. Check the scope of each clearance; features outside it are not cleared.