Pearl, a global leader in AI solutions for dentistry, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AI-powered detection of dental pathologies on panoramic radiographs.
The approval expands Pearl’s clinically validated radiologic AI technology to the most widely captured extraoral imaging modality in dentistry and is now available to Second Opinion® users in the U.S. and internationally.
The clearance allows Pearl’s real-time, chairside platform to identify and highlight suspected caries, periapical radiolucencies, and impacted third molars on panoramic X-rays.
These images provide a comprehensive view of dental and maxillofacial anatomy, but their complexity can make consistent and accurate diagnosis challenging. Pearl’s AI aims to improve diagnostic accuracy, consistency, and efficiency.
“Panoramic X-rays capture the full mouth at lower radiation than traditional full-mouth series, yet remain one of the hardest dental X-rays to read reliably,” said Ophir Tanz, founder and CEO of Pearl. “AI brings clarity and certainty to interpretation.
Patients also benefit from clearer, labeled diagnoses. While adoption in the U.S. lags behind Europe and the U.K., this FDA clearance demonstrates the strength of our technology and moves the industry closer to universal AI support in dental care.”
The clearance follows extensive clinical validation, including a standalone performance study and a multi-reader, multi-case (MRMC) study.
Results showed that Second Opinion significantly improves detection of caries, periapical radiolucencies, and impacted third molars across all subgroups, including gender, geography, and imaging device type.
With this FDA approval, Pearl now offers the most comprehensive radiologic AI platform in dentistry, covering bitewing, periapical, panoramic, and CBCT imaging.
Panoramic AI support is available both in Pearl’s standalone software and through integrations with numerous imaging and practice management systems, allowing seamless adoption within existing clinical workflows.