GeneralDevices & AI clearances

FDA Clears Dentsply Sirona DS Core CBCT Anatomy

U.S. FDA2w ago

FDA has cleared Dentsply Sirona's DS Core CBCT Anatomy via the 510(k) pathway; the device is listed under radiology product code QIH.

  • The clearance was reviewed by the FDA's Radiology committee.
  • The applicant is Dentsply Sirona.
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