Pearl Achieves FDA Clearance for Both 2D and 3D Dental Imaging, Setting a New Standard in AI-Driven Dentistry
Pearl, the global leader in dental AI solutions, has achieved a groundbreaking milestone by receiving FDA 510(k) clearance for its Second Opinion® 3D platform. This clearance makes Pearl the first and only dental AI company with FDA-approved solutions for both 2D and 3D radiologic image analysis, solidifying its position as the most advanced dental AI platform in the world.
With this new development, Pearl’s Second Opinion® 3D expands its industry-leading AI capabilities to cone beam computed tomography (CBCT) imaging. The platform now enables automated identification of critical anatomical structures—including dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway—in 3D scans. This advancement empowers dental professionals to review CBCT scans with greater speed, accuracy, and clarity, ultimately enhancing diagnostics and treatment planning across specialties such as implantology, orthodontics, oral surgery, and airway management.
A Milestone for Dentistry and AI Innovation
“Pearl’s mission has always been to deliver the most advanced and clinically trusted AI solutions in dentistry,” said Ophir Tanz, founder and CEO of Pearl. “Becoming the first company to achieve FDA clearance for both 2D and 3D radiologic analysis isn’t just a milestone for us—it’s a milestone for dentistry.”
This achievement underscores Pearl’s commitment to pushing the boundaries of what AI can do in healthcare. By extending its AI capabilities to CBCT imaging, Pearl is addressing a growing need in the dental industry for tools that streamline workflows while improving diagnostic precision.
How Second Opinion® 3D Transforms CBCT Imaging
The Second Opinion® 3D platform is designed to assist dental professionals in reviewing CBCT scans more efficiently and accurately. Leveraging advanced AI algorithms, the platform provides instant visualizations of anatomical structures, enabling clinicians to make faster and more informed decisions. These AI-powered insights support a wide range of applications, including:
- Implantology: Precise identification of bone density and anatomical landmarks to optimize implant placement.
- Orthodontics: Enhanced visualization of tooth positioning and jaw structure for comprehensive treatment planning.
- Oral Surgery: Accurate mapping of critical structures like the inferior alveolar nerve to minimize risks during procedures.
- Airway Management: Detailed analysis of nasal spaces and airways to aid in diagnosing and treating conditions like sleep apnea.
By automating these complex tasks, Second Opinion® 3D reduces the time and effort required for manual review, allowing dental professionals to focus on delivering exceptional patient care.
Proven Accuracy and Safety
The FDA clearance for Second Opinion® 3D follows rigorous bench performance testing, during which the platform demonstrated high segmentation accuracy across all targeted anatomical structures. Dice Similarity Coefficient (DSC) scores—a standard metric for evaluating image segmentation accuracy—exceeded clinical thresholds for every category, confirming both the safety and effectiveness of the solution.
This level of precision ensures that clinicians can trust the AI-generated insights provided by Second Opinion® 3D, further enhancing its value as a diagnostic tool.
Building on a Legacy of Regulatory Leadership
Pearl’s original Second Opinion® platform remains the most widely deployed FDA-cleared solution for chairside AI pathology detection in 2D radiographs. Since its introduction, the platform has been used by thousands of dental professionals worldwide, helping them identify pathologies such as caries, periapical lesions, and restorative issues with unmatched accuracy.
With the addition of 3D capabilities, Pearl now offers the only FDA-cleared platform capable of supporting comprehensive radiologic review across both major dental imaging modalities—2D radiographs and CBCT scans. This dual capability reinforces Pearl’s leadership in regulatory compliance and innovation within the dental AI space.
Why This Matters for Dental Professionals
For dental professionals, the integration of AI into radiologic analysis represents a transformative shift in how they approach diagnostics and treatment planning. Traditional methods of reviewing CBCT scans can be time-consuming and prone to human error, particularly when identifying subtle or complex anatomical structures.
Second Opinion® 3D addresses these challenges by providing:
- Enhanced Efficiency: Automated identification of structures reduces the time needed for manual review, allowing clinicians to see more patients and improve practice productivity.
- Improved Accuracy: AI-driven insights minimize the risk of oversight, ensuring that critical findings are not missed during diagnosis.
- Better Patient Outcomes: With more precise diagnostics, clinicians can develop tailored treatment plans that lead to better outcomes for their patients.
As dental practices increasingly adopt advanced imaging technologies, tools like Second Opinion® 3D will play a vital role in maximizing the value of these investments.
A Vision for the Future of Dentistry
Pearl’s latest achievement reflects its ongoing commitment to advancing dental care through AI innovation. By bridging the gap between 2D and 3D imaging, Pearl is setting a new standard for what’s possible in radiologic analysis.
Looking ahead, Pearl aims to continue expanding its AI capabilities to address additional challenges in dentistry. Whether it’s improving diagnostic accuracy, streamlining workflows, or enhancing patient communication, Pearl is dedicated to empowering dental professionals with cutting-edge tools that elevate the quality of care.
Join the AI Revolution in Dentistry
For dental practices seeking to stay ahead of the curve, Second Opinion® 3D offers a powerful solution for integrating AI into daily workflows. With FDA clearance for both 2D and 3D imaging, Pearl is uniquely positioned to help practices unlock the full potential of their imaging technologies.
About Pearl
Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl’s AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry’s global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit hellopearl.com/getdemo
