Second Opinion® 3D expands Pearl’s leading AI technology to CBCT scans, making it the most advanced dental AI platform globally.
LOS ANGELES — Pearl, a global leader in dental artificial intelligence (AI), announced today that it has received FDA 510(k) clearance for its Second Opinion® 3D product. This approval makes Pearl the first and only dental AI company to have FDA-cleared solutions for both 2D and 3D dental image analysis.
With this clearance, Pearl’s Second Opinion® platform now supports cone beam computed tomography (CBCT) imaging.
This technology can automatically detect key anatomical features such as teeth, upper jaw (maxilla), lower jaw (mandible), the inferior alveolar nerve canal (IAN), maxillary sinus, nasal cavity, and airway in 3D scans.
Ophir Tanz, Pearl’s founder and CEO, said, “Our goal has always been to provide the most advanced and trusted AI solutions for dentistry. Being the first to receive FDA clearance for both 2D and 3D radiologic analysis is a major achievement—not just for us, but for the entire dental field.”
Second Opinion® 3D helps dental professionals review CBCT scans more quickly and accurately. The AI provides instant visual insights, aiding dentists in making better diagnoses and treatment plans. This support benefits various specialties, including implantology, orthodontics, oral surgery, and airway management.
The FDA clearance came after thorough testing, where Second Opinion® 3D showed high accuracy in identifying all targeted anatomical structures. The product exceeded clinical safety and effectiveness standards, measured by Dice Similarity Coefficient scores.
This new clearance adds to Pearl’s strong history as a regulatory pioneer in dental AI. Their original Second Opinion® platform remains the most widely used FDA-cleared AI tool for detecting pathologies in 2D dental X-rays. Now, with 3D imaging added, Pearl offers the only FDA-cleared AI platform that covers the two main types of dental radiology.
