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Independent. Every regulatory claim links to its FDA filing.Editorial policyCorrectionsUpdated Oct 26, 2026
AI Dental ToolsThe independent reference for AI in dental practice
Bottom line

Pearl is the safer pick for 2D x-rays: its clearances cover caries, calculus, periapical findings and bone level on bitewings and periapicals, panoramic films from age 16 (K250525) and pediatric caries from age 4 (K243893). Both have a CBCT clearance, but Pearl's (K243989) marks anatomy, while Diagnocat's (K252934) flags periapical radiolucency. Diagnocat also publishes self-serve prices; Pearl quotes through sales.

Diagnocat or Pearl: which should you choose?

Choose Diagnocat if
  • Most of the scans you want read are CBCT, for implants, endodontics or surgery
  • You would rather sign up online at a listed price (plans with CBCT reports start at €590 for six months) than wait for a sales quote
  • You want CBCT segmentation and STL export (the STL output is cleared for educational use only)
Choose Pearl if
  • Multi-condition screening on bitewings and periapicals
  • Case acceptance conversations with AI-annotated x-rays
  • Practice-wide quality metrics via the analytics dashboard

Diagnocat vs Pearl: FDA clearances, price and integrations side by side

DiagnocatPearl
VendorDGNCT LLC (Diagnocat) · Miami, FLPearl Inc. · Los Angeles, CA
CategoryImaging & diagnosticsImaging & diagnostics
FDA 510(k)K252934 (Jan 15, 2026); K251072 (Sep 9, 2025)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 forConcurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older. / Segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only.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 modalitiesCBCT, panoramic, intraoralbitewing, periapical, CBCT
PricingFrom €499/year (Self-serve subscription, 6 or 12 months)Not published (Contact sales)
IntegrationsDentsply Sirona, Vatech, Planmeca, CarestreamEaglesoft, Dentrix, Open Dental, Curve Dental, Carestack
Best fitspecialist, ortho, oral-surgerygroup, dso
Last verifiedOct 25, 2026Oct 22, 2026

From each vendor's site and the FDA 510(k) database. Diagnocat price: diagnocat.com.

Strengths and limits

Diagnocat
  • FDA-cleared AI second read on CBCT scans for periapical radiolucency (K252934)
  • Lists self-serve plan prices on its website; most dental imaging AI vendors quote only after a demo
  • Covers intraoral, panoramic, and CBCT imaging in one platform, with 3D models and STL export (STL cleared for educational use only)
  • Newer to the US market than established competitors, with limited domestic clinical validation data
  • No US clearance covers its 2D (bitewing, periapical, panoramic) findings
  • Self-serve plans are priced in euros, do not connect to the x-ray machine, and unused reports expire at the end of each term
  • CBCT integration workflow may require verification with your specific scanner manufacturer
Pearl
  • Detects more pathology types than most competitors in a single analysis
  • 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 Diagnocat and Pearl?

Pearl is the safer pick for 2D x-rays: its clearances cover caries, calculus, periapical findings and bone level on bitewings and periapicals, panoramic films from age 16 (K250525) and pediatric caries from age 4 (K243893). Both have a CBCT clearance, but Pearl's (K243989) marks anatomy, while Diagnocat's (K252934) flags periapical radiolucency. Diagnocat also publishes self-serve prices; Pearl quotes through sales.

Which is FDA cleared, Diagnocat or Pearl?

Diagnocat: K252934, K251072. Pearl: K250525, K243234, K243989, K243230, K243893, K242600, K242522, K210365. Check the scope of each clearance; features outside it are not cleared.