Cleared Traditional

AIR-FLOW HANDY 3.0 PERIO

K132480 · E.M.S Electro Medical Systems S.A · Dental
Feb 2014
Decision
200d
Days
Class 1
Risk

About This 510(k) Submission

K132480 is an FDA 510(k) clearance for the AIR-FLOW HANDY 3.0 PERIO, 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 February 24, 2014, 200 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 K132480 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2013
Decision Date February 24, 2014
Days to Decision 200 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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