Cleared Traditional

K043136 - ELITY 70 X-RAY

K043136 is an FDA 510(k) clearance for ELITY 70 X-RAY, manufactured by Dental X-Ray E.U.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K043136 · Dental X-Ray E.U. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
55d
Days
Class 2
Risk

K043136 is an FDA 510(k) clearance for the ELITY 70 X-RAY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Dental X-Ray E.U. (Miami, US). The FDA issued a Cleared decision on January 6, 2005 after a review of 55 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.

FDA 510(k) Submission Details - K043136

510(k) Number K043136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date January 06, 2005
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
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 188
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K043136.
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
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IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
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MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
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CRANEX D
K043307 · Soredex Palodex Group OY · Dec 2004
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
K043092 · Progeny, Inc. · Dec 2004
PHOT-X II, MODEL 303
K042260 · Takara Belmont USA, Inc. · Sep 2004
K043136 · ELITY 70 X-RAY
Download PDF FDA Summary Dental X-Ray E.U.