Cleared Traditional

K071133 - APEXNRG-BLUE ELECTRONIC APEX LOCATOR

K071133 · Medicnrg , Ltd. · Dental device
Download Printable Device Report (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.

View all Medicnrg , Ltd. devices

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
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · 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

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