FDA 510(k), K103711, ORTHOPHOS XG 3D / CEPH

FDA 510(k), K103711, ORTHOPHOS XG 3D / CEPH

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510(K) Number: K103711
Device Name: ORTHOPHOS XG 3D / CEPH
Manufacturer: SIRONA DENTAL SYSTEMS GMBH
Device Classification Name: x-ray, tomography, computed, dental
Regulation Number: 892.1750
Classification Product Code: OAS
Date Received: 12/20/2010
Decision Date: 03/22/2011
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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