Cleared Traditional

K961235 - SIRIUS 180, 180L, 230, 230L

K961235 is an FDA 510(k) clearance for SIRIUS 180, manufactured by Micro-Mega Societe Anonyme. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K961235 · Micro-Mega Societe Anonyme · Dental device
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Jan 1997
Decision
285d
Days
Class 1
Risk

K961235 is an FDA 510(k) clearance for the SIRIUS 180, 180L, 230, 230L. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on January 8, 1997 after a review of 285 days - an extended review 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: 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 - K961235

510(k) Number K961235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date January 08, 1997
Days to Decision 285 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 128d · This submission: 285d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, 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 - EFB Handpiece, Air-powered, Dental

All 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K961235.
SANI-SHIELD
K970104 · Dw Industries, Inc. · May 1997
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT
K963843 · Micro Motors, Inc. · Mar 1997
SIRIUS 10, 10L, 40, 40L
K961275 · Micro-Mega Societe Anonyme · Jan 1997
DENTAL HANDPIECE AND ACCESSORY
K963664 · Filmtech, Inc. · Oct 1996
MIDWEST 300 SE
K962877 · Midwest Dental Products Corp. · Oct 1996
TRADITION P, PUSH BUTTON HANDPIECE
K963050 · Midwest Dental Products Corp. · Oct 1996
K961235 · SIRIUS 180, 180L, 230, 230L
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