Cleared Traditional

ORTHOPHOS XG 3D / CEPH

K103711 · Sirona Dental Systems GmbH · Radiology
Mar 2011
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K103711 is an FDA 510(k) clearance for the ORTHOPHOS XG 3D / CEPH, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on March 22, 2011, 92 days after receiving the submission on December 20, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K103711 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2010
Decision Date March 22, 2011
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.