Cleared Traditional

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

K190124 · E.M.S Electro Medical Systems S.A · Dental
Oct 2019
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K190124 is an FDA 510(k) clearance for the EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on October 20, 2019, 268 days after receiving the submission on January 25, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K190124 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2019
Decision Date October 20, 2019
Days to Decision 268 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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