- What it does: Pearl's Second Opinion is an AI platform that analyzes dental radiographs and highlights pathologies for the clinician. Its clearance covers a broader set of conditions than most competitors: caries, periapical lesions, calculus, bone loss, and other detectable findings. It integrates with five major practice management systems and includes a Practice Intelligence module for practice or DSO-level metrics. Pearl was founded in 2019 by Ophir Tanz.
- Regulatory: 8 FDA 510(k) clearances (K250525, K243234, K243989, K243230, K243893, K242600, K242522, K210365)
- Pricing: Not published (Contact sales)
- Best fit: group, dso
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.
Pearl vs alternatives
- DentalXR.AI Pro vs Pearl
- Dentistry.AI vs Pearl
- Diagnocat vs Pearl
- Orca Dental AI vs Pearl
- Pearl vs Retrace
- Pearl vs VideaHealth
Other imaging & diagnostics tools we track: Overjet (quote only, 12 FDA clearances), Dentsply Sirona DS Core (quote only, 4 FDA clearances), Velmeni (quote only, 4 FDA clearances), VideaHealth (quote only, 4 FDA clearances).
Is Pearl FDA cleared?
Yes. Pearl holds 8 FDA 510(k) clearances: K250525 (Nov 14, 2025) for marks suspected caries, periapical radiolucency and impacted third molars on panoramic radiographs, patients 16 and older.; K243234 (Jun 12, 2025) for second Opinion CS: detection and segmentation of caries on periapical radiographs, permanent teeth, patients 12 and older (second reader).; K243989 (May 23, 2025) for second Opinion 3D: marks anatomy on CBCT (dentition, maxilla, mandible, inferior alveolar canal, sinus, airway).; K243230 (May 9, 2025) for second Opinion BLE: bone-level measurements on bitewing and periapical radiographs, patients 12 and older.; K243893 (May 5, 2025) for second Opinion Pediatric: caries detection on bitewing and periapical radiographs, patients 4 and older (primary or mixed dentition).; K242600 (Apr 11, 2025) for periapical radiolucency detection with outlined regions on periapical radiographs, permanent teeth, patients 12 and older (second reader).; K242522 (Jan 16, 2025) for second Opinion CC: caries detection with outlined regions on bitewing and periapical radiographs, patients 19 and older (second reader).; K210365 (Mar 4, 2022) for second Opinion: detection of caries, calculus, periapical radiolucency and other findings on bitewing and periapical radiographs.. Features outside those indications are not covered by the clearance.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K250525 | Second Opinion® Panoramic | Nov 14, 2025 | Marks suspected caries, periapical radiolucency and impacted third molars on panoramic radiographs, patients 16 and older. |
| K243234 | Second Opinion® CS | Jun 12, 2025 | Second Opinion CS: detection and segmentation of caries on periapical radiographs, permanent teeth, patients 12 and older (second reader). |
| K243989 | Second Opinion® 3D | May 23, 2025 | Second Opinion 3D: marks anatomy on CBCT (dentition, maxilla, mandible, inferior alveolar canal, sinus, airway). |
| K243230 | Second Opinion® BLE | May 9, 2025 | Second Opinion BLE: bone-level measurements on bitewing and periapical radiographs, patients 12 and older. |
| K243893 | Second Opinion® Pediatric | May 5, 2025 | Second Opinion Pediatric: caries detection on bitewing and periapical radiographs, patients 4 and older (primary or mixed dentition). |
| K242600 | Second Opinion Periapical Radiolucency Contours | Apr 11, 2025 | Periapical radiolucency detection with outlined regions on periapical radiographs, permanent teeth, patients 12 and older (second reader). |
| K242522 | Second Opinion CC | Jan 16, 2025 | Second Opinion CC: caries detection with outlined regions on bitewing and periapical radiographs, patients 19 and older (second reader). |
| K210365 | Second Opinion | Mar 4, 2022 | Second Opinion: detection of caries, calculus, periapical radiolucency and other findings on bitewing and periapical radiographs. |
What Pearl does
Imaging modalities: bitewing, periapical, CBCT.
- Multi-pathology detection (caries, periapical radiolucencies, calculus, bone loss and more)
- Practice Intelligence analytics module
- Other products on Pearl's site: Second Opinion 3D (CBCT), Voice, RCM, Calibrate and Precheck
How much does Pearl cost?
Pearl does not publish pricing; it is quoted by sales (Contact sales). Pricing is not published; contact the vendor.
- 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
Where it fits
- Multi-condition screening on bitewings and periapicals
- Case acceptance conversations with AI-annotated x-rays
- Practice-wide quality metrics via the analytics dashboard
Common questions
What does Pearl integrate with?
Pearl lists integrations with Eaglesoft, Dentrix, Open Dental, Curve Dental, Carestack. 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 8 clearance(s). Added K242522, K242600, K243230, K243234, K243893, K243989, K250525.
- 2026-10-22: Added CBCT: Second Opinion 3D was cleared under K243989 (May 23, 2025).