Cleared Traditional

K133406 - CS 8100 3D

K133406 is the FDA 510(k) clearance for CS 8100 3D by Trophy. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K133406 · Trophy · Radiology device
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Mar 2014
Decision
128d
Days
Class 2
Risk

K133406 is an FDA 510(k) clearance for the CS 8100 3D. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Trophy (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on March 14, 2014 after a review of 128 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.

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Submission Details

510(k) Number K133406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date March 14, 2014
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
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 90
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K133406.
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
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ORTHOPHOS SL
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K132983 · VATECH Co., Ltd. · Aug 2014
PHT-6500, PHT-60CFO
K130432 · VATECH Co., Ltd. · May 2013
GALILEOS FAMILY
K123070 · Sirona Dental Systems GmbH · Mar 2013
PAX-UNI3D, PHT-7500
K121400 · VATECH Co., Ltd. · Aug 2012