Pearl becomes the first dental AI company with FDA-cleared solutions for both 2D and 3D radiologic image analysis following new clearance for its CBCT imaging platform.
Dental AI company Pearl has received 510(k) clearance from the U.S. Food and Drug Administration for Second Opinion 3D, its artificial intelligence tool for analyzing cone beam computed tomography (CBCT) scans. The clearance makes Pearl the first company in the dental AI space to hold FDA approvals for both 2D and 3D radiologic image analysis.
The newly cleared technology enables automated identification of several anatomical structures in CBCT scans, including dentition, the maxilla and mandible, the inferior alveolar canal, mental foramen, maxillary sinus, nasal cavity, and airway.
Tool Designed to Support Faster, More Precise Diagnoses
Pearl says Second Opinion 3D is intended to help clinicians review 3D imaging studies more efficiently and accurately. The platform provides instant visualizations to assist with diagnosis and treatment planning in areas such as orthodontics, implantology, oral surgery, and airway management.
“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.”
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Accuracy Validated in Bench Testing
The FDA’s clearance followed performance testing that evaluated the platform’s ability to accurately segment anatomical structures. Pearl reports that the system’s Dice Similarity Coefficient scores exceeded clinical thresholds across all categories tested, supporting its safety and effectiveness.
Expanding an Existing FDA-Cleared Platform
The clearance extends Pearl’s Second Opinion platform, which is already in clinical use as an FDA-cleared tool for detecting pathologies in 2D dental radiographs. The addition of 3D capabilities allows the company to offer what it describes as the only FDA-cleared dental AI platform covering both major imaging modalities.
