FDA 510(k) Cleared

Broadest FDA-cleared pathology detection for dental radiographs

Pearl by Pearl · Los Angeles, CA

AI-powered dental imaging platform with pathology detection across radiograph types.

FDA 510(k): K210365

Pearl’s Second Opinion product is an AI platform that analyzes dental radiographs and highlights pathologies for the clinician. Where some dental AI tools focus on one or two conditions (caries detection, bone level measurement), Pearl’s clearance covers a broader set: caries, periapical lesions, calculus, bone loss, and several other detectable conditions. The trade-off is depth versus breadth — Pearl covers more conditions but provides less granular quantitative data per condition compared to tools like Overjet.

The platform integrates with five major practice management systems, making it one of the most widely compatible dental AI tools. Pearl also includes a Practice Intelligence module that tracks detection rates, treatment acceptance patterns, and clinical metrics across a practice or DSO — adding a business analytics layer on top of the clinical detection engine.

+ Strengths

  • Detects more pathology types than most competitors in a single analysis
  • Widest PMS integration coverage — works with 5+ major systems
  • Practice Intelligence adds business analytics on top of clinical detection

− Limitations

  • Enterprise pricing model — cost unclear until sales conversation
  • Detection accuracy is condition-dependent — strongest on caries, weaker on marginal bone loss

Key Use Cases

01

Multi-condition screening on bitewings and periapicals

02

Case acceptance conversations with AI-annotated x-rays

03

Practice-wide quality metrics via the analytics dashboard

Verdict

Pearl covers the widest range of dental pathologies in a single FDA-cleared product. If your practice wants one AI tool that screens for caries, lesions, calculus, and bone loss simultaneously, Pearl is the leading option. The Practice Intelligence dashboard adds value for multi-location practices tracking clinical consistency. Confirm pricing against your patient volume before committing.

Platform Integrations

EaglesoftDentrixOpen DentalCurve DentalCarestack

Integrations

Eaglesoft, Dentrix, Open Dental, Curve Dental, Carestack

Sources

Related Articles

Dental AI FDA Clearance Tracker: Every 510(k) Clearance for AI-Powered Dental Imaging Tools A maintained reference of every FDA 510(k) clearance for dental AI imaging and diagnostic tools. Updated when new clearances are published.
How Dental AI X-Ray Tools Charge You — Per Seat, Per Scan, Per Location (2026 Pricing Guide) A breakdown of how dental AI imaging tools price their software — per provider, per scan, per location, or enterprise-wide. What's publicly available, what's behind sales calls, and questions to ask before signing.
Overjet vs. Pearl: What the FDA 510(k) Clearance Letters Actually Say (A Side-by-Side Reading) A side-by-side comparison of Overjet and Pearl based on their actual FDA 510(k) clearance letters, confirmed PMS integrations, and publicly available documentation — not vendor marketing.

Alternatives

Overjet Clinical AI — Diagnostic Imaging VideaHealth Clinical AI — Diagnostic Imaging