Cleared Traditional

K071133 - APEXNRG-BLUE ELECTRONIC APEX LOCATOR

K071133 · Medicnrg , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
151d
Days
-
Risk

K071133 is an FDA 510(k) clearance for the APEXNRG-BLUE ELECTRONIC APEX LOCATOR. Classified as Locator, Root Apex (product code LQY).

Submitted by Medicnrg , Ltd. (Somerset, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K071133

510(k) Number K071133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date September 21, 2007
Days to Decision 151 days
Submission Type Traditional
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
23d slower than avg
Panel avg: 128d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

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 K071133.
NAVI ROOT
K083901 · S-Denti Co., Ltd. · Apr 2009
APX21
K073185 · Techdent Technologies, Ltd. · Mar 2008
APEX DAL ELECTRONIC APEX LOCATOR
K080113 · Medicnrg , Ltd. · Feb 2008
APEXNRG XFR
K063843 · Medicnrg , Ltd. · Jan 2007
NSK PRECISION APEX LOCATOR (PAL)
K053235 · Medicsense USA · Jan 2006
APEX NRG
K032743 · Medicnrg , Ltd. · Mar 2004
K071133 · APEXNRG-BLUE ELECTRONIC APEX LOCATOR
Download PDF FDA Summary Medicnrg , Ltd.