Cleared Abbreviated

K061114 - WDS, SIZE 2 AND SIZE 2

K061114 is an FDA 510(k) clearance for WDS, manufactured by Cefla S.C.R.L.. The device is a Class 2 Radiology device with product code MUH cleared through the Abbreviated 510(k) pathway after a 46-day FDA review.

K061114 · Cefla S.C.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
46d
Days
Class 2
Risk

K061114 is an FDA 510(k) clearance for the WDS, SIZE 2 AND SIZE 2. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Cefla S.C.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on June 6, 2006 after a review of 46 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cefla S.C.R.L. devices

FDA 510(k) Submission Details - K061114

510(k) Number K061114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date June 06, 2006
Days to Decision 46 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Standards-based clearance path.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 106
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K061114.
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · VATECH Co., Ltd. · Apr 2008
VERAVIEWEPOCS
K073696 · J. Morita USA, Inc. · Apr 2008
PLANMECA PROONE
K072244 · Planmeca Oy · Sep 2007
GALILEOS
K060892 · Sirona Dental Systems GmbH · Apr 2006
PLANMECA PROMAX 3D
K060328 · Planmeca Oy · Mar 2006
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
K060079 · Eastman Kodak Company · Feb 2006