Cleared Traditional

EMS AIR-FLOW MASTER PIEZON

K110173 · E.M.S Electro Medical Systems S.A · Dental
Apr 2011
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K110173 is an FDA 510(k) clearance for the EMS AIR-FLOW MASTER PIEZON, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on April 7, 2011, 77 days after receiving the submission on January 20, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K110173 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2011
Decision Date April 07, 2011
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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