Cleared Traditional

K060640 - DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM

K060640 is an FDA 510(k) clearance for DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM, manufactured by Dentamerica. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K060640 · Dentamerica · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
45d
Days
Class 2
Risk

K060640 is an FDA 510(k) clearance for the DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Dentamerica (Industry, US). The FDA issued a Cleared decision on April 24, 2006 after a review of 45 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 Dentamerica devices

FDA 510(k) Submission Details - K060640

510(k) Number K060640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date April 24, 2006
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
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 104
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K060640.
PLANMECA PROSENSOR
K091197 · Planmeca Oy · Jul 2009
HELIODENT PLUS
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PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · Genoray Co., Ltd. · Jan 2007
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · Planmeca Oy · Jun 2005
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
K050019 · Kavo America · Jan 2005
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · Eastman Kodak Company · Apr 2004