Cleared Traditional

K971774 - NSK PUSH-BUTTON MIDWEST REPLACEMENT TUR...

K971774 is the FDA 510(k) clearance for NSK PUSH-BUTTON MIDWEST REPLACEMENT TUR... by Nsk Nakanishi, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K971774 · Nsk Nakanishi, Inc. · Dental device
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Jun 1997
Decision
38d
Days
Class 1
Risk

K971774 is an FDA 510(k) clearance for the NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on June 20, 1997 after a review of 38 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.

View all Nsk Nakanishi, Inc. devices

Submission Details

510(k) Number K971774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1997
Decision Date June 20, 1997
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 78
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