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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K151912
Device Name AIR-FLOW handy 3.0 PLUS
Applicant
E.M.S Electro Medical Systems S.A
Rte De Champ-Colin 2
Nyon,  CH CH-1260
Applicant Contact Suzanne Fassio-Hardy
Correspondent
E.M.S Electro Medical Systems S.A
Rte De Champ-Colin 2
Nyon,  CH CH-1260
Correspondent Contact Suzanne Fassio-Hardy
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/13/2015
Decision Date 02/03/2016
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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