Cleared Traditional

K961494 - SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE

K961494 is an FDA 510(k) clearance for SERIES XE 140XE, manufactured by Micro-Mega Societe Anonyme. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K961494 · Micro-Mega Societe Anonyme · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
69d
Days
Class 1
Risk

K961494 is an FDA 510(k) clearance for the SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE. 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 June 26, 1996 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Mega Societe Anonyme devices

FDA 510(k) Submission Details - K961494

510(k) Number K961494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date June 26, 1996
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

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

All 31
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K961494.
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · W&H Dentalwerk Buermoos GmbH · Jun 2001
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
K972569 · Nsk Nakanishi, Inc. · Oct 1997
SERIES XE, SERIES SE, SERIES TE
K971350 · Micro-Mega Societe Anonyme · Jun 1997
ORAL PROCEDURE PACK
K950743 · Transidyne General Corp. · Mar 1995
PROPHYLAXIS PACK
K950773 · Transidyne General Corp. · Mar 1995
M4 CONTRA-ANGLE HANDPIECE
K942480 · Kerr Corporation (Danbury) · Jan 1995