A U.S.-based dental technology company has made history by becoming the first to receive FDA clearance for artificial intelligence (AI) software capable of analyzing both 2D and 3D dental images.
Pearl, headquartered in California, announced Tuesday that its Second Opinion® 3D platform has received FDA 510(k) clearance, expanding its AI capabilities to cone beam computed tomography (CBCT) imaging. The company had previously received FDA clearance in 2022 for its 2D radiographic analysis platform, Second Opinion®.
“Becoming the first company to achieve FDA clearance for both 2D and 3D radiologic analysis isn’t just a milestone for us—it’s a milestone for dentistry,” said Ophir Tanz, founder and CEO of Pearl. “Our mission has always been to deliver the most advanced and clinically trusted AI solutions in dentistry.”