Cleared Traditional

AIR-FLOW HANDY 3.0

K132478 · E.M.S Electro Medical Systems S.A · Dental
Apr 2014
Decision
246d
Days
Class 1
Risk

About This 510(k) Submission

K132478 is an FDA 510(k) clearance for the AIR-FLOW HANDY 3.0, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by E.M.S Electro Medical Systems S.A (Marlborough, US). The FDA issued a Cleared decision on April 11, 2014, 246 days after receiving the submission on August 8, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K132478 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2013
Decision Date April 11, 2014
Days to Decision 246 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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