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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
Applicant
E.M.S Electro Medical Systems S.A
Chemin De La Vuarpilliere 31
Nyon,  CH CH-1260
Applicant Contact Gaelle Pacaud
Correspondent
Ultra Life Science Solutions, Inc.
872 S. Milwaukee Ave.
Libertyville,  IL  60048
Correspondent Contact Christina Henza
Regulation Number872.4850
Classification Product Code
ELC  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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