Pearl, the global leader in dental AI solutions, today announced a series of FDA 510(k) clearances (K242522, K242600, K243234) expanding the capabilities of its Second Opinion® AI platform to include advanced segmentation for caries and periapical radiolucency detection.
By bringing that same level of precision to dentistry, we’re giving clinicians a clearer, more intuitive view of pathology that improves both diagnostic accuracy and patient communication.
These clearances replace traditional bounding boxes with AI-generated polygonal contours, providing dentists with a more clinically meaningful view of each finding. By delivering precise lesion shapes and detailed contextual information—such as enamel and dentin overlap—Second Opinion® segmentation gives clinicians deeper insight to inform diagnosis and treatment planning.
“Segmentation has long been the standard in medical imaging AI for fields like oncology and radiology,” said Ophir Tanz, founder and CEO of Pearl. “By bringing that same level of precision to dentistry, we’re giving clinicians a clearer, more intuitive view of pathology that improves both diagnostic accuracy and patient communication.”
This milestone builds on Pearl’s track record of regulatory leadership, strengthening Second Opinion® as one of the most comprehensive FDA-cleared platforms for dental radiographic analysis and ensuring that dental professionals have access to AI that meets the highest standards of clinical rigor and reliability.
About Pearl
Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl's AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry’s global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit hellopearl.com/getdemo.
