Cleared Special

K063843 - APEXNRG XFR

K063843 · Medicnrg , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
8d
Days
-
Risk

K063843 is an FDA 510(k) clearance for the APEXNRG XFR. Classified as Locator, Root Apex (product code LQY).

Submitted by Medicnrg , Ltd. (Somerset, US). The FDA issued a Cleared decision on January 3, 2007 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063843

510(k) Number K063843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date January 03, 2007
Days to Decision 8 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 128d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 42
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K063843.
APX21
K073185 · Techdent Technologies, Ltd. · Mar 2008
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K071133 · Medicnrg , Ltd. · Sep 2007
NSK PRECISION APEX LOCATOR (PAL)
K053235 · Medicsense USA · Jan 2006
APEX NRG
K032743 · Medicnrg , Ltd. · Mar 2004
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · Aseptico, Inc. · Dec 2003
K063843 · APEXNRG XFR
Download PDF FDA Summary Medicnrg , Ltd.