Cleared Traditional

K854741 - X-RANGE 65

K854741 is an FDA 510(k) clearance for X-RANGE 65, manufactured by Alpine Dental Equipment Co.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K854741 · Alpine Dental Equipment Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
101d
Days
Class 2
Risk

K854741 is an FDA 510(k) clearance for the X-RANGE 65. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Alpine Dental Equipment Co. (East Orange, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 101 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 Alpine Dental Equipment Co. devices

FDA 510(k) Submission Details - K854741

510(k) Number K854741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1985
Decision Date March 06, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
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 149
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K854741.
MAMMOTEST PRODUCT, MODIFICATION
K926575 · Fischer Imaging Corp. · Mar 1993
ORTHOPANTOMOGRAPH 100
K912893 · Instrumentarium Corp. · Nov 1991
ORTHOPHOS AND ORTHOPHOS C
K895467 · Siemens Medical Solutions USA, Inc. · Nov 1989
GE 900
K811103 · General Electric Co. · Jun 1981
GENERAL ELECTRIC PANELIPSE LD
K792581 · General Electric Co. · Jan 1980
DENTAL X-RAY UNIT
K781286 · Siemens Corp. · Sep 1978