Cleared Traditional

K964659 - ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

K964659 is an FDA 510(k) clearance for ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM, manufactured by Dentsply Intl.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K964659 · Dentsply Intl. · Radiology device
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Dec 1996
Decision
33d
Days
Class 2
Risk

K964659 is an FDA 510(k) clearance for the ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Dentsply Intl. (Des Plaines, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 33 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K964659

510(k) Number K964659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date December 23, 1996
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
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 141
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K964659.
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
K965072 · Kaycor Intl., Ltd. · Jan 1997
ACURAY DIGITAL X-RAY
K963403 · New Image Industries, Inc. · Jan 1997
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
K963699 · Belmont Equipment Corp. · Dec 1996
DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
K962631 · Fair Image, Inc. · Nov 1996
ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER
K963185 · Electronic Control Concepts · Oct 1996
DIGIPAN
K961826 · Trophy Radiologie · Sep 1996