Cleared Traditional

K962877 - MIDWEST 300 SE

K962877 is an FDA 510(k) clearance for MIDWEST 300 SE, 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 86-day FDA review.

K962877 · Midwest Dental Products Corp. · Dental device
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Oct 1996
Decision
86d
Days
Class 1
Risk

K962877 is an FDA 510(k) clearance for the MIDWEST 300 SE. 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 October 18, 1996 after a review of 86 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 - K962877

510(k) Number K962877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1996
Decision Date October 18, 1996
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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 K962877.
SIRIUS 10, 10L, 40, 40L
K961275 · Micro-Mega Societe Anonyme · Jan 1997
SIRIUS 180, 180L, 230, 230L
K961235 · Micro-Mega Societe Anonyme · Jan 1997
DENTAL HANDPIECE AND ACCESSORY
K963664 · Filmtech, Inc. · Oct 1996
TRADITION P, PUSH BUTTON HANDPIECE
K963050 · Midwest Dental Products Corp. · Oct 1996
AIR MOTOR HANDPIECE TN-102
K962542 · Nsk Nakanishi, Inc. · Sep 1996
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
K962543 · Nsk Nakanishi, Inc. · Sep 1996
K962877 · MIDWEST 300 SE
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