Cleared Traditional

K103123 - APEX POINTER+

Also marketed or referenced as:
MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
K103123 · Micro-Mega Societe Anonyme · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
140d
Days
-
Risk

K103123 is an FDA 510(k) clearance for the APEX POINTER+. Classified as Locator, Root Apex (product code LQY).

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on March 10, 2011 after a review of 140 days - within the typical 510(k) review window.

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 - K103123

510(k) Number K103123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2010
Decision Date March 10, 2011
Days to Decision 140 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
12d slower than avg
Panel avg: 128d · This submission: 140d
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 K103123.
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ROMIAPEX MODEL A-15
K101054 · Romidan, Ltd. · Sep 2010
K103123 · APEX POINTER+
Download PDF FDA Summary Micro-Mega Societe An…