Second Opinion® 3D

by Pearl  · Based in United States → — FDA-cleared AI for Dental CBCT
Dentistry Radiology
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Subscription-based
Regulatory Status Disclosed

Overview

Second Opinion® 3D by Pearl is an FDA-cleared AI-powered radiological automated image processing software designed to transform complex dental CBCT scans into clear, actionable 3D insights. It assists dental professionals in reviewing CBCT radiographs with greater speed, accuracy, and clarity by providing automated segmentation and color-coded anatomy. The tool highlights clinically significant pathology and identifies critical anatomical structures such as dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway. This cloud-based solution allows clinicians to review scans in minutes, customize visualizations, and control image views for in-depth review and planning. It supports various dental disciplines including implantology, orthodontics, oral surgery, and general dentistry, enhancing diagnostic confidence and patient communication.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared AI for 3D radiology
  • Transforms CBCT scans into clear 3D insights
  • Automated segmentation and color-coded anatomy
  • Highlights clinically significant pathology
  • Fast AI analysis in minutes
  • Customizable visualizations
  • Image control (toggle, isolate, zoom)
  • Supports implant planning, surgical prep, and presentation
  • Aids in identifying asymmetries, lesions, and anomalies for referral
  • Cloud-based portal for scan submission and analysis

Use Cases

  • Expedite CBCT review and interpretation
  • Enhance implant planning and placement
  • Assist in surgical preparation for oral procedures
  • Improve patient education and communication regarding diagnoses
  • Aid in orthodontic treatment planning
  • Support airway management assessments
  • Facilitate early detection of caries, bone loss, and infections

What Physicians Need to Know

Dental X-Ray Analysis
FDA-cleared AI for dental CBCT scans, transforming complex scans into clear, actionable 3D insights in minutes. It provides automated segmentation, color-coded anatomy, and highlighted findings. It identifies and marks clinically relevant anatomy such as dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway.
Caries Detection Accuracy
While Second Opinionu00ae 3D primarily focuses on 3D anatomical insights from CBCT scans, the broader Pearl Second Opinion platform is FDA-cleared and validated to detect dental disease with 94% accuracy, aiding in catching early decay.
Periodontal Assessment
Second Opinionu00ae 3D aids in visualizing bone health through 3D anatomical segmentation. The broader Pearl Second Opinion platform includes FDA-cleared AI for automated bone level analysis (Second Opinionu00ae BLE) in 2D radiographs, streamlining periodontal evaluation and supporting earlier diagnosis of periodontal disease.
Treatment Planning AI
Designed to improve diagnostics and treatment planning in implantology, orthodontics, oral surgery, and airway management. It provides annotated visuals for implant planning, surgical prep, or presentation, including the potential for 3D printed models.
Dental Imaging Integration (CBCT/Panoramic)
Second Opinionu00ae 3D is specifically designed for CBCT scans, transforming them into intuitive, color-coded 3D visualizations. The comprehensive Pearl Second Opinion platform supports integration with various imaging platforms for both 2D (bitewing, periapical, panoramic) and 3D (CBCT) radiographs.
Practice Management Integration
The broader Pearl Second Opinion platform integrates with practice management systems (PMS) to streamline workflows, surfacing chairside radiograph findings directly in the PMS to support documentation and case presentation.
Patient Communication Tools
Facilitates clear communication of clinical rationale to specialists and patients using labeled, color-coded 3D visuals. The platform provides compelling case presentation tools with clear visuals and AI highlights, which can increase case acceptance by over 30%.
Orthodontic Planning
Second Opinionu00ae 3D is designed to improve diagnostics and treatment planning in orthodontics by providing deeper insights into 3D data and identifying key anatomical structures like dentition, maxilla, and mandible.
Physician Tip

Second Opinionu00ae 3D serves as an assistive tool and a 'second set of eyes'; the ultimate responsibility for diagnosis and treatment decisions remains with the practitioner. Leverage its customizable visualizations and image control for in-depth review and planning. Utilize the clear, color-coded 3D visuals for effective patient education to enhance understanding and improve case acceptance. The tool can help identify asymmetries, lesions, and anomalies that may warrant further investigation or referral.

Second Opinionu00ae 3D operates as a cloud-based portal for submitting and analyzing CBCT scans. The broader Pearl Second Opinion platform offers seamless integration with various existing imaging software (e.g., Carestream Dental's CS Imaging, VisiQuick, Oryx, SOTACloud) and practice management systems (e.g., Software of Excellence's EXACT, Oryx), supporting effortless viewing of AI annotations directly within existing clinical workflows.

Details

Category Dental AI
Pricing Subscription-based — One-off setup fee: $500 USD; Monthly subscription: $299 USD/month
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Pearl's Second Opinion® 3D received FDA 510(k) clearance (K243989) on May 23, 2025. It is intended to identify and mark clinically relevant anatomy in dental CBCT radiographs for patients 12 years of age or older, specifically dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway.
Integrations
EHR Not specified
Specialties Dentistry, Radiology

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Press & Coverage

Pearl (hellopearl.com)
Pearl Becomes First Dental AI Company Cleared by FDA for Both 2D and 3D Imaging
Pearl announced it received FDA 510(k) clearance for Second Opinionu00ae 3D, making it the first dental AI company with FDA-cleared solutions for both 2D and 3D dental radiologic image analysis. This expands Pearl's AI capabilities to CBCT imaging, enabling automated identification of critical anatomical structures in 3D scans.
2025-05
Pearl (hellopearl.com)
Pearl Receives Industry-First EU-MDR Certification for Second Opinionu00ae AI Platform
Pearl's Second Opinionu00ae chairside dental pathology detection aid was granted a certification recommendation as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR), making Pearl the first company in AI-driven computer-aided dental detection software to obtain this certification.
2023-06
Pearl (hellopearl.com)
Pearl Granted Patent for Second Opinionu00ae AI Software
Pearl announced that the United States Patent and Trademark Office issued U.S Patent No. 11,676,701, granting Pearl exclusive rights to the computer system technology supporting the API of its chairside AI disease detection software, Second Opinionu00ae. This is the tenth patent for Pearl's dental AI technology.
2023-06
Pearl (hellopearl.com)
Pearl Expands Pediatric Capabilities with Second Opinionu00ae for Kids
Pearl launched Second Opinionu00ae for Kids, expanding the pediatric capabilities of its flagship radiologic AI platform with a new, kid-friendly interface that builds on Pearl's real-time disease detection capabilities.
2025-09
Pearl (hellopearl.com)
Pearl Expands Global Footprint with Vatech Integration
Pearl and Vatech announced a global partnership to integrate Pearl's Second Opinionu00ae into Vatech's imaging solutions, expanding AI technologies to aid in dental diagnosis for Vatech's global customer base.
2025-03
Pearl (hellopearl.com)
Pearl Secures FDA Clearance for Pediatric AI in Dental Radiography
Pearl received FDA 510(k) clearance for Second Opinionu00ae Pediatric, allowing the platform to assist dentists in detecting caries for pediatric patients as young as 4 years old with primary or mixed dentition.
2025-09
Pearl (hellopearl.com)
Pearl Expands Dental AI Capabilities with FDA Clearance for Panoramic X-Rays
Pearl announced that the FDA granted 510(k) clearance for AI-powered detection of dental pathologies on panoramic radiographs, expanding Pearl's clinically validated radiologic AI technology to this widely captured extraoral imaging modality.
2025-12
International Dental Journal (via PMC)
FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook - PMC
This review catalogs FDA-cleared AI solutions in dental imaging, noting that more advanced systems like Pearl Second Opinion 3D were designed to process CBCT data for virtual modeling.
2025-12

Videos

Product demos, reviews, and walkthroughs for Second Opinion® 3D.

View all on YouTube

Frequently Asked Questions

Second Opinionu00ae 3D integrates seamlessly with existing imaging and practice management systems, allowing for a streamlined workflow without switching between multiple software programs. It transforms complex CBCT scans into intuitive, color-coded 3D visualizations, automatically segmenting key oral-maxillofacial anatomy and highlighting findings to assist in faster and more accurate diagnostics and treatment planning across specialties like implantology, orthodontics, oral surgery, and airway management.
Second Opinionu00ae 3D has received FDA 510(k) clearance, making Pearl the first and only dental AI company with FDA-cleared solutions for both 2D and 3D dental radiologic image analysis. This clearance signifies that the FDA has deemed the software safe and effective as a chairside detection aid for dentists, ensuring it meets high standards of clinical rigor and reliability.
Second Opinionu00ae 3D is distinguished by being the first FDA-cleared AI for 3D dental radiology, offering automated segmentation and color-coded insights into CBCT data in minutes. Unlike traditional second opinions which involve subjective human interpretation, the AI provides consistent, data-driven analyses, acting as an objective 'second set of eyes' to enhance diagnostic accuracy and patient communication.
Second Opinionu00ae 3D operates on a subscription-based model, offering flexible monthly subscriptions and volume-based pricing. Practices may experience cost savings through improved efficiency, earlier detection of issues leading to less invasive and costly treatments, and enhanced patient understanding which can increase case acceptance.
While highly accurate, Second Opinionu00ae 3D is an assistive tool and does not replace the practitioner's professional judgment; the ultimate responsibility for diagnosis and treatment decisions remains with the dentist. Its effectiveness can also depend on factors like image quality and consistent image capture techniques. Physicians should critically evaluate AI suggestions, using them to augment their expertise rather than as a sole diagnostic basis.
Pearl, the developer of Second Opinionu00ae 3D, takes data privacy and security seriously, implementing measures to maintain patient privacy. This includes heavily encrypting and de-identifying personal data, ensuring that even in the event of a security breach, it would be impossible to associate patient names with the actual data.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed Second Opinion® 3D

Funded through the company that built this tool.

Left Lane Capital
VC T1
New York, United States
$5M-$25M
Left Lane Capital is a New York-based growth-equity firm that has built a focused practice around consumer-facing internet and software companies, with…
Care Delivery / Tech-Enabled Services Digital Health
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