Pearl, a California-based dental technology company, has achieved a historic regulatory milestone by becoming the first company to receive FDA 510(k) clearance for artificial intelligence software capable of analyzing both 2D and 3D dental images. The company announced that its Second Opinion® 3D platform has received FDA clearance, expanding its AI capabilities to cone beam computed tomography (CBCT) imaging.
Expanding AI Capabilities to 3D Imaging
The newly cleared Second Opinion® 3D platform 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. This advancement builds upon Pearl's existing Second Opinion® platform, which received FDA clearance in 2022 for 2D radiographic analysis.
"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."
Clinical Performance and Applications
The FDA clearance follows extensive bench performance testing, where Second Opinion® 3D demonstrated high segmentation accuracy across all targeted anatomical structures. Dice Similarity Coefficient scores exceeded clinical thresholds for every category, confirming both safety and effectiveness of the platform.
According to Pearl, 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.
Market Position and Regulatory Leadership
With this new clearance, Pearl now offers the only FDA-cleared AI platform capable of supporting comprehensive radiologic review across both major dental imaging modalities. The company's original Second Opinion® platform remains the most widely deployed FDA-cleared solution for chairside AI pathology detection in 2D radiographs.
While Pearl's clearance represents a first for AI-based platforms in dental imaging, several non-AI dental imaging systems have previously received FDA approval, including Planmeca's ProMax® 3D CBCT system and Carestream Dental's CS 9600 system for 3D dental and maxillofacial imaging.
