A U.S.-based dental technology company has made history by becoming the first to receive FDA clearance for artificial intelligence (AI) software capable of analyzing both 2D and 3D dental images.
Pearl, headquartered in California, announced Tuesday that its Second Opinion® 3D platform has received FDA 510(k) clearance, expanding its AI capabilities to cone beam computed tomography (CBCT) imaging. The company had previously received FDA clearance in 2022 for its 2D radiographic analysis platform, Second Opinion®.
“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,” said Ophir Tanz, founder and CEO of Pearl. “Our mission has always been to deliver the most advanced and clinically trusted AI solutions in dentistry.”
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What can it do?
The newly cleared Second Opinion® 3D enables automated identification of key anatomical structures in CBCT scans, including dentition, the maxilla and mandible, the inferior alveolar canal and mental foramen, the maxillary sinus, nasal cavity, and airway.
According to the company, the platform allows dental professionals to review CBCT scans with greater speed, accuracy and clarity. It provides instant AI-powered visualizations to support more precise diagnostics and treatment planning across specialties such as implantology, orthodontics, oral surgery and airway management.
Pearl says it now offers the only FDA-cleared AI platform capable of supporting comprehensive radiologic review across both major dental imaging modalities.
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Plethora of non-AI imaging systems
While Pearl’s clearance is a first for AI-based platforms, several non-AI dental imaging systems have previously received FDA approval. For example, Planmeca’s ProMax® 3D CBCT system is cleared for diagnostic and treatment planning use, and Carestream Dental’s CS 9600 system is FDA-cleared for 3D dental and maxillofacial imaging.
However, AI is increasingly being integrated into a wide range of applications, including dental imaging. Last year, researchers at North Carolina State University developed a technique that allows AI to reconstruct 3D spaces from 2D images captured by multiple cameras, a method that could improve autonomous vehicle navigation by reducing computational demands.
Earlier, in 2019, a team at the University of California, Los Angeles, enhanced fluorescence microscopy using AI to convert 2D images into detailed 3D visualizations. This advancement allowed scientists to observe activity inside living cells and tissues with greater depth and precision.