Cleared Traditional

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE (K972375) - FDA 510(k) Clearance

Class I Dental device.

K972375 · Glenwood, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
77d
Days
Class 1
Risk

K972375 is an FDA 510(k) clearance for the IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Glenwood, LLC (Piscataway, US). The FDA issued a Cleared decision on September 10, 1997 after a review of 77 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 Glenwood, LLC devices

Submission Details

510(k) Number K972375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date September 10, 1997
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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
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