First FDA clearance granted for AI platform analyzing both 2D and 3D dental images

CALIFORNIA, USA: In a groundbreaking development for digital dentistry, Pearl, a U.S.-based dental technology company, has received FDA clearance for its artificial intelligence (AI) software capable of analyzing both 2D and 3D dental images. This clearance establishes Pearl's Second Opinion® 3D as the first and only AI platform approved to assist in both cone beam computed tomography (CBCT) and traditional 2D dental radiographs.

Pearl had previously received FDA clearance for its 2D AI platform in 2022. With this new approval, the company cements its position as a pioneer in AI-driven dental diagnostics.

“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.

What does Second Opinion® 3D do?

The AI software allows clinicians to identify complex anatomical structures in CBCT scans quickly and accurately, enhancing diagnostic precision and improving treatment planning. The system identifies critical structures such as:

• Dentition
• Mandible and maxilla
• Inferior alveolar canal and mental foramen
• Maxillary sinus
• Nasal cavity
• Upper airway

This 3D AI analysis is particularly valuable for specialists in implantology, orthodontics, oral surgery, and airway-focused treatments. The platform integrates seamlessly with clinical workflows, offering instant AI visualizations to help practitioners save time while improving diagnostic accuracy.

Industry-first milestone for AI in dental imaging

While numerous CBCT systems such as Planmeca ProMax® 3D and Carestream CS 9600 have received FDA approval for imaging purposes, Pearl is the first to secure approval for AI-powered diagnostic review across both imaging modalities. This makes Second Opinion® 3D a unique player in the AI health tech space.

The approval arrives at a time when AI integration is rapidly growing in healthcare. The decision by the FDA also signals increasing regulatory confidence in AI applications for radiologic diagnostics.

Future of AI in clinical dentistry

Pearl’s achievement is more than a regulatory milestone—it represents the beginning of a new era where machine learning tools are trusted to assist with complex clinical judgments. The combination of clinical accuracy, speed, and AI-based consistency promises to empower dental professionals and enhance patient care worldwide.

Pearl’s expanded AI suite now offers the only FDA-cleared platform that supports full-spectrum radiologic review—paving the way for safer, smarter, and more informed dental decision-making.