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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K171189
Device Name AIR-FLOW PLUS Prophylaxis powder
Applicant
E.M.S Electro Medical Systems S.A
Chemin De La Vuarpilliere 31
Nyon,  CH CH-1260
Applicant Contact Suzanne Fassio-Hardy
Correspondent
Can-Do-Medical
Mundelein,  IL  60060
Correspondent Contact Christina Henza
Regulation Number872.6030
Classification Product Code
EJR  
Date Received04/24/2017
Decision Date 09/11/2017
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
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