Cleared Traditional

K963843 - ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT

K963843 is an FDA 510(k) clearance for ELECTRIC SURGICAL IRRIGATION SYSTEM - D..., manufactured by Micro Motors, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K963843 · Micro Motors, Inc. · Dental device
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Mar 1997
Decision
187d
Days
Class 1
Risk

K963843 is an FDA 510(k) clearance for the ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro Motors, Inc. (Encinitas, US). The FDA issued a Cleared decision on March 31, 1997 after a review of 187 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.

View all Micro Motors, Inc. devices

FDA 510(k) Submission Details - K963843

510(k) Number K963843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date March 31, 1997
Days to Decision 187 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
60d slower than avg
Panel avg: 127d · This submission: 187d
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 104
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