Cleared Special

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (K022119) - FDA 510(k) Clearance

Class I Dental device.

K022119 · Electro Medical Systems SA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
24d
Days
Class 1
Risk

K022119 is an FDA 510(k) clearance for the EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Electro Medical Systems SA devices

Submission Details

510(k) Number K022119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date July 25, 2002
Days to Decision 24 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K022119.
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