Cleared Traditional

MICRO RSH HIGH SPEED HANDPIECE (K935676) - FDA 510(k) Clearance

Class I Dental device.

K935676 · Micro Motors, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
490d
Days
Class 1
Risk

K935676 is an FDA 510(k) clearance for the MICRO RSH HIGH SPEED HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro Motors, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 490 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Micro Motors, Inc. devices

Submission Details

510(k) Number K935676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date March 31, 1995
Days to Decision 490 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
363d slower than avg
Panel avg: 127d · This submission: 490d
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 K935676.
ESTYLUS ELECTRIC MOTOR SYSTEM
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K012720 · Dentsply Intl. · Nov 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987