Cleared Traditional

K100960 - WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

K100960 is an FDA 510(k) clearance for WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS, manufactured by Cefla Dental Group. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K100960 · Cefla Dental Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
197d
Days
Class 2
Risk

K100960 is an FDA 510(k) clearance for the WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Cefla Dental Group (North Attleboro, US). The FDA issued a Cleared decision on October 21, 2010 after a review of 197 days - an extended review 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 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 Cefla Dental Group devices

FDA 510(k) Submission Details - K100960

510(k) Number K100960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2010
Decision Date October 21, 2010
Days to Decision 197 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
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 99
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K100960.
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