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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scaler, ultrasonic
510(k) Number K190124
Device Name EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
E.M.S Electro Medical Systems S.A.
Chemin de la Vuarpilliere 31
nyon,  CH ch-1260
Applicant Contact gaelle pacaud
Ultra LifeScience Solutions Inc.
872 S. Milwaukee Ave
libertyville,  IL  60048
Correspondent Contact christina henza
Regulation Number872.4850
Classification Product Code
Date Received01/25/2019
Decision Date 10/20/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No