We at Masset are thrilled to congratulate our friends at Pearl for achieving a landmark FDA clearance: on May 27, 2025, the U.S. Food & Drug Administration granted 510(k) clearance for Pearl’s groundbreaking Second Opinion® 3D. This achievement makes Pearl the first—and only—dental AI company authorized to analyze both 2D radiographs and 3D cone-beam computed tomography (CBCT) scans.
Why This Is a Game-Changer for Dentistry
Unified Imaging Workflow:Dental professionals can now depend on one AI-driven platform to consistently evaluate bitewings, periapicals, panoramic X-rays, and comprehensive CBCT scans. This streamlined approach significantly improves diagnostic accuracy and efficiency.
Enhanced Anatomical Insights:Second Opinion® 3D precisely identifies key anatomical structures such as teeth, the maxilla, mandible, inferior alveolar canal, mental foramen, maxillary sinus, nasal space, and airway. This capability empowers clinicians in implantology, orthodontics, oral surgery, and airway management with deeper insights for more accurate treatment planning.
Regulatory Leadership:This FDA clearance solidifies Pearl’s unique status as the only dental AI solution approved for both major imaging modalities. It highlights AI's growing significance in elevating patient care and setting new standards in global dentistry.
Pearl’s Visionary Impact
In the words of Pearl’s Founder and CEO, Ophir Tanz:
“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.”
Pearl's innovation is set to help dental professionals worldwide deliver faster diagnoses, enhanced accuracy, and improved patient outcomes. We’re excited to witness the transformative impact this achievement will have on global oral health.
Congratulations once again to the Pearl team!
— The Masset Team
