Pearl, the global leader in AI solutions for dentistry, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AI-powered detection of key dental pathologies on panoramic radiographs. This milestone expands Pearl’s FDA-validated radiologic AI platform to include the most widely used extraoral imaging modality in dentistry, making the technology available to Second Opinion® users in the U.S. and internationally. The clearance enables Pearl’s Second Opinion real-time chairside pathology detection platform to identify and highlight suspected caries, periapical radiolucencies, and impacted third molars on panoramic x-rays. These images provide a comprehensive view of the entire mouth and maxillofacial region, but their complex anatomy and inherent distortion have historically made consistent and accurate interpretation challenging for clinicians. “Panoramic x-rays are increasingly popular because they capture the full mouth with lower radiation exposure than traditional full-mouth series, but they remain one of the most difficult types of dental x-ray to read reliably,” said Ophir Tanz, founder and CEO of Pearl. “AI brings greater clarity and certainty to pano interpretation. Patients benefit as well: Diagnoses are easier to understand when findings are clearly highlighted and labeled. Although panoramic x-ray adoption in the U.S. still lags behind the U.K. and Europe, this FDA clearance affirms the strength of our technology and moves the industry closer to universal AI support across dental radiology.” The FDA clearance is backed by rigorous clinical validation, including a standalone performance study and a fully crossed multi-reader, multi-case (MRMC) study. The results demonstrate that Pearl’s Second Opinion significantly improves the detection of caries, periapical radiolucencies, and impacted third molars across all study subgroups—regardless of gender, geographic region, or imaging device type—confirming the AI’s stable and unbiased performance. With this expansion, Pearl now offers the most comprehensive FDA-cleared radiologic AI platform in dentistry, covering bitewing, periapical, panoramic, and cone beam computed tomography (CBCT) imaging. For existing Second Opinion® users, panoramic AI support is available both within Pearl’s standalone software and through native integrations with dozens of dental imaging and practice management systems, enabling seamless adoption within current clinical workflows. Pearl, founded in 2019 by a team with deep expertise in enterprise-grade computer vision, introduced the first-ever FDA-cleared AI capable of instantly detecting diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl’s technology empowers dentists to make more precise clinical decisions and communicate findings more effectively with patients, transforming the dental care experience worldwide. The company remains committed to advancing accessible, reliable AI tools that improve patient outcomes and strengthen trust in dental medicine. For a demo, visit hellopearl.com/getdemo.