Cleared Traditional

K151912 - AIR-FLOW handy 3.0 PLUS

K151912 is an FDA 510(k) clearance for AIR-FLOW handy 3.0 PLUS, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 1 Dental device with 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

FDA 510(k) Submission Details - K151912

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 127d · This submission: 205d
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 162
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K151912.
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