Cleared Traditional

K151912 - AIR-FLOW handy 3.0 PLUS

K151912 is the FDA 510(k) clearance for AIR-FLOW handy 3.0 PLUS by E.M.S Electro Medical Systems S.A. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K151912 · E.M.S Electro Medical Systems S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
205d
Days
Class 1
Risk

K151912 is an FDA 510(k) clearance for the AIR-FLOW handy 3.0 PLUS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on February 3, 2016 after a review of 205 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K151912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date February 03, 2016
Days to Decision 205 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
78d slower than avg
Panel avg: 127d · This submission: 205d
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
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K151912.
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