Pearl Becomes 1st Dental AI Company with FDA Nods for 2D & 3D Imaging

Pearl, a company focused on dental artificial intelligence (AI) solutions, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Second Opinion 3D tool.

According to the company, the FDA nod makes it the first, only dental AI company with FDA-cleared solutions for both 2D and 3D dental radiologic image analysis.

Pearl’s Second Opinion platform’s AI capabilities now extend to cone beam computed tomography (CBCT) imaging. This enables automated identification of structures including dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway in 3D scans.

Second Opinion 3D provides AI-powered visualizations to support more precise diagnostics and treatment planning across implantology, orthodontics, oral surgery, and airway management.

The clearance follows bench performance testing in which the tool showed high segmentation accuracy in all targeted anatomical structures. Dice Similarity Coefficient scores surpassed clinical thresholds for every category, the company said, confirming safety and effectiveness.

“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.”

Last month, the company began a partnership with to integrate Second Opinion into Vatech’s imaging solutions.