Cleared Traditional

AIR-FLOW handy 3.0 PLUS

K151912 · E.M.S Electro Medical Systems S.A · Dental
Feb 2016
Decision
205d
Days
Class 1
Risk

About This 510(k) Submission

K151912 is an FDA 510(k) clearance for the AIR-FLOW handy 3.0 PLUS, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on February 3, 2016, 205 days after receiving the submission on July 13, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K151912 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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