Cleared Traditional

K122582 - DENTAL X-RAY Z70 (W)

Also marketed or referenced as:
DENTAL X-RAY Z70 (M) DENTAL X-RAY Z70 (C)

K122582 is an FDA 510(k) clearance for DENTAL X-RAY Z70 (W), manufactured by Denterprise International, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K122582 · Denterprise International, Inc. · Radiology device
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Dec 2012
Decision
106d
Days
Class 2
Risk

K122582 is an FDA 510(k) clearance for the DENTAL X-RAY Z70 (W). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Denterprise International, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 106 days - within the typical 510(k) review window.

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 Denterprise International, Inc. devices

FDA 510(k) Submission Details - K122582

510(k) Number K122582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date December 07, 2012
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

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 81
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