Pearl has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for AI-powered detection of dental pathologies on panoramic radiographs. The clearance extends the company’s clinically validated radiologic AI technology to panoramic imaging, one of the most commonly used extraoral modalities in dentistry, and is now available to Second Opinion users in the US and other markets. The milestone supports Pearl’s ongoing aim to enhance diagnostic accuracy, consistency and efficiency across dental care.
With the latest clearance, Pearl’s Second Opinion real-time chairside pathology detection platform can identify and highlight suspected caries, periapical radiolucencies, and impacted third molars on panoramic radiographs. While panoramic images provide a comprehensive anatomical overview, their inherent distortion and complexity can make reliable interpretation challenging. The FDA decision confirms the performance of Pearl’s radiologic AI when applied to this diagnostically demanding imaging format.
Commenting on the development, Ophir Tanz, founder and chief executive officer of Pearl, noted that panoramic radiographs are increasingly used because they capture the full dentition at a lower radiation dose than a traditional full-mouth series, yet remain difficult to interpret consistently. He added that AI can improve clarity and confidence in interpretation, while also helping patients better understand diagnoses through clearly highlighted findings. Although panoramic imaging is more widely adopted in the UK and Europe than in the US, the clearance reflects the robustness of Pearl’s technology and supports broader adoption of AI in dental radiology.
The clearance is underpinned by extensive clinical validation, including a standalone performance study and a fully crossed multi-reader, multi-case (MRMC) study. Results showed that Second Opinion improved the detection of caries, periapical radiolucencies, and impacted third molars, with stable and unbiased performance across subgroups including gender, geography, and imaging device type.
Following this approval, Pearl further consolidates its position as a comprehensive FDA-cleared radiologic AI platform in dentistry, covering bitewing, periapical, panoramic and CBCT imaging. Panoramic AI functionality is available to existing Second Opinion users through Pearl’s standalone software as well as via integrations with numerous imaging and practice management systems, enabling adoption within established clinical workflows.
All images courtesy of Pearl.
