Cleared Traditional

K103711 - ORTHOPHOS XG 3D / CEPH

K103711 is an FDA 510(k) clearance for ORTHOPHOS XG 3D / CEPH, manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K103711

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
Combination Product No
PCCP Authorized No
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.

OAS Device Classification - Class 2, Special Controls

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 128
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K103711.
SCANORA 3D
K110839 · Soredex Palodex Group OY · Jun 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · Qr S.R.L. · Apr 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · VATECH Co., Ltd. · Mar 2011
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · VATECH Co., Ltd. · Jan 2010
PAX-500
K082350 · VATECH Co., Ltd. · Oct 2008
FINECUBE DENTAL CT
K063622 · The Yoshida Dental Mfg. Co., Ltd. · Feb 2007