Pearl, the global leader in dental AI solutions, today announced that it has received FDA 510(k) clearance for Second Opinion® BLE, an advanced feature that enables automated bone level measurement in bitewing and periapical radiographs.
With this clearance, Pearl is making it faster and easier for dentists to perform accurate periodontal analysis, enhancing their ability to deliver high-quality patient care.
With this clearance, dentists can leverage Pearl’s AI to instantly visualize mesial and distal bone levels with precision, reducing the time required for manual measurements and ensuring a more standardized approach to periodontal evaluation. This breakthrough gives dental professionals an AI-powered second reader that supports earlier diagnosis of periodontal disease and more effective treatment planning.
“Bone level evaluation has traditionally been a time-intensive process,” said Ophir Tanz, founder and CEO of Pearl. “With this clearance, Pearl is making it faster and easier for dentists to perform accurate periodontal analysis, enhancing their ability to deliver high-quality patient care.”
This clearance expands Pearl’s FDA-cleared AI portfolio with a powerful new tool for periodontal assessment, furthering the company’s mission to equip dentists with technology that drives greater accuracy, efficiency, and consistency in patient 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.