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Pearl Becomes First Dental AI Company with FDA Clearance for Both 2D and 3D Imaging

Summary by Orthodontic Products
Pearl becomes the first dental AI company with FDA-cleared solutions for both 2D and 3D radiologic image analysis following new clearance for its CBCT imaging platform. Dental AI company Pearl has received 510(k) clearance from the U.S. Food and Drug Administration for Second Opinion 3D, its artificial intelligence tool for analyzing cone beam computed tomography (CBCT) scans. The clearance makes Pearl the first company in the dental AI space to…
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Orthodontic Products broke the news in on Tuesday, May 27, 2025.
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