Cleared Traditional

K113497 - HYPERION

K113497 is an FDA 510(k) clearance for HYPERION, manufactured by Cefla S.C. Cefla Dental Group. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K113497 · Cefla S.C. Cefla Dental Group · Radiology device
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Jan 2012
Decision
53d
Days
Class 2
Risk

K113497 is an FDA 510(k) clearance for the HYPERION. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Cefla S.C. Cefla Dental Group (Imola, IT). The FDA issued a Cleared decision on January 17, 2012 after a review of 53 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cefla S.C. Cefla Dental Group devices

FDA 510(k) Submission Details - K113497

510(k) Number K113497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2011
Decision Date January 17, 2012
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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
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