Cleared Traditional

K032743 - APEX NRG

K032743 · Medicnrg , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
193d
Days
-
Risk

K032743 is an FDA 510(k) clearance for the APEX NRG. Classified as Locator, Root Apex (product code LQY).

Submitted by Medicnrg , Ltd. (Ramat Hasharon,, IL). The FDA issued a Cleared decision on March 15, 2004 after a review of 193 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 - K032743

510(k) Number K032743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2003
Decision Date March 15, 2004
Days to Decision 193 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
65d slower than avg
Panel avg: 128d · This submission: 193d
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 K032743.
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NSK PRECISION APEX LOCATOR (PAL)
K053235 · Medicsense USA · Jan 2006
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · Aseptico, Inc. · Dec 2003
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
K022020 · Toei Electric Co., Ltd. · Jul 2002
K032743 · APEX NRG
Download PDF FDA Summary Medicnrg , Ltd.