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FDA Clears Dentix AI Device to Screen Standard Dental X-Rays

April 21, 2023

The FDA has granted 510(k) clearance to Dexis’ DTX Studio Clinic’s imaging tool that can detect six dental pathologies on standard, two-dimensional periapical and bitewing x-rays.

The new function is integrated into the DTX Studio Clinic, a software package that manages image acquisition, diagnosis and treatment planning.

The six dental pathologies the device can find are caries, discrepancy at margin, root canal defects, periapical radiolucency, bone loss and calculus, the company said.

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