Cleared Traditional

K042171 - AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 (FDA 510(k) Clearance)

Class I Dental device.

K042171 · Micro-Mega Societe Anonyme · Dental device
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Nov 2004
Decision
91d
Days
Class 1
Risk

K042171 is an FDA 510(k) clearance for the AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230.... Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on November 10, 2004 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. 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 Micro-Mega Societe Anonyme devices

Submission Details

510(k) Number K042171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2004
Decision Date November 10, 2004
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

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