Cleared Traditional

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

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K103711 is an FDA 510(k) clearance for the ORTHOPHOS XG 3D / CEPH. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on March 22, 2011 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K103711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 129
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