Cleared Traditional

K955655 - MIDWEST ONE

K955655 is an FDA 510(k) clearance for MIDWEST ONE, manufactured by Midwest Dental Products Corp.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K955655 · Midwest Dental Products Corp. · Dental device
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Mar 1996
Decision
84d
Days
Class 1
Risk

K955655 is an FDA 510(k) clearance for the MIDWEST ONE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Midwest Dental Products Corp. (Des Plaines, US). The FDA issued a Cleared decision on March 5, 1996 after a review of 84 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.

FDA 510(k) Submission Details - K955655

510(k) Number K955655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date March 05, 1996
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
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 K955655.
MM 324
K961076 · Micro-Mega Societe Anonyme · Apr 1996
LARES RESEARCH AS-1 LOWSPEED HANDPIECE
K961163 · Lares Research, Inc. · Apr 1996
LYNX DPA DISPOSABLE PROPHY ANGLE
K960541 · Mti Precision Products · Mar 1996
ALLRAP/SLIP-N-GRIP
K960352 · Dental Disposables Intl., Inc. · Feb 1996
SHORTSTOP DISPOSABLE PROPHY ANGLE
K955654 · Spintech, Inc. · Feb 1996
MTC 7707 HIGH SPEED AIR TURBINE
K945256 · Mtc Industries and Research, Ltd. · Jan 1996
K955655 · MIDWEST ONE
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