Cleared Special

K080113 - APEX DAL ELECTRONIC APEX LOCATOR

K080113 · Medicnrg , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
30d
Days
-
Risk

K080113 is an FDA 510(k) clearance for the APEX DAL ELECTRONIC APEX LOCATOR. Classified as Locator, Root Apex (product code LQY).

Submitted by Medicnrg , Ltd. (Somerset, US). The FDA issued a Cleared decision on February 15, 2008 after a review of 30 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 - K080113

510(k) Number K080113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2008
Decision Date February 15, 2008
Days to Decision 30 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
98d faster than avg
Panel avg: 128d · This submission: 30d
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 K080113.
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
NAVI ROOT
K083901 · S-Denti Co., Ltd. · Apr 2009
APX21
K073185 · Techdent Technologies, Ltd. · Mar 2008
APEXNRG-BLUE ELECTRONIC APEX LOCATOR
K071133 · Medicnrg , Ltd. · Sep 2007
APEXNRG XFR
K063843 · Medicnrg , Ltd. · Jan 2007
NSK PRECISION APEX LOCATOR (PAL)
K053235 · Medicsense USA · Jan 2006
K080113 · APEX DAL ELECTRONIC APEX LOCATOR
Download PDF FDA Summary Medicnrg , Ltd.