Pearl, the global leader in dental AI solutions, today announced that it has received FDA 510(k) clearance for Second Opinion® Pediatric, enabling the platform to assist dentists in detecting caries for pediatric patients as young as 4 years old with primary or mixed dentition.
With this clearance, we’re ensuring that even the youngest patients benefit from the precision and consistency of AI-assisted dentistry.
With this new clearance, Pearl’s Second Opinion® platform broadens its clinical utility, helping dental professionals provide earlier, more accurate detection of caries in younger patients. By extending AI-powered radiographic analysis to pediatric care, Pearl is empowering dentists to deliver a higher standard of care to every patient, regardless of age.
“Pearl’s mission has always been to provide technology that enhances clinical confidence and improves patient outcomes,” said Ophir Tanz, founder and CEO of Pearl. “With this clearance, we’re ensuring that even the youngest patients benefit from the precision and consistency of AI-assisted dentistry.”
This clearance reinforces Pearl’s position as a regulatory leader in dental AI. By adding pediatric capabilities to Second Opinion®, Pearl is expanding the platform’s clinical reach, helping dentists deliver consistent, AI-powered radiographic support for patients at every stage of care.
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.
