Cleared Special

K033073 - ORTHOPHOS XG DS/CEPH (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033073 · Sirona Dental Systems GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
11d
Days
Class 2
Risk

K033073 is an FDA 510(k) clearance for the ORTHOPHOS XG DS/CEPH. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on October 10, 2003 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K033073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date October 10, 2003
Days to Decision 11 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 188
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K033073.
NOMAD Pro 3
K253864 · Dental Imaging Technologies Corporation · Mar 2026
Dental X-RAY Unit (AJX200)
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · Mar 2026
Portable Dental X-ray Device (GT-1)
K254018 · Guilin Refine Medical Instrument Co., Ltd. · Feb 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Feb 2026
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2025
Rextar Pro
K242185 · Raypia Co., Ltd. · Dec 2024