Pearl, a Los Angeles-based dental artificial intelligence company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Second Opinion® 3D platform.
According to the company, this clearance makes Pearl the first and only dental AI company with FDA-cleared 2D and 3D dental radiography image analysis solutions.
The newly cleared platform expands Pearl’s existing AI capabilities to cone beam CT (CBCT) imaging. According to the company, Second Opinion® 3D can automatically identify key anatomical structures in 3D scans, including the dentition, maxilla, mandible, alveolar canal and mental foramen, maxillary sinuses, nasal cavity, and airway.
“Pearl’s mission has always been to provide the most advanced, clinically trusted AI solutions in dentistry,” said Pearl founder and CEO Ophir Tanz.
Being the first company to receive FDA clearance for both 2D and 3D radiology analysis is not only a milestone for us, but for the dental community as well,” said Pearl founder and CEO Ophir Tanz.
According to the company, Second Opinion® 3D is designed to help dental professionals review CBCT scans with greater speed, accuracy and visual clarity.
The system generates AI-powered visualizations designed to support diagnostic and treatment planning workflows in specialties such as implant dentistry, orthodontics, oral surgery and airway management.
The software received FDA clearance after undergoing performance testing. According to Pearl, the software demonstrated high segmentation accuracy for all target anatomies, with Dice similarity coefficient scores exceeding clinical thresholds.
Pearl’s original Second Opinion® platform remains an FDA-cleared AI tool for chairside pathology detection in 2D radiographs.
With the addition of 3D capabilities, Pearl now offers a platform that, according to the company, is the only one cleared by the FDA for use with both major dental imaging modalities.
Related topics:
