Cleared Traditional

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT (K963843) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

Device Classification

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 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K963843.
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DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
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K897101 · Dentsply Intl. · Mar 1990
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987