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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 K112869
Model EASYPROPHY 200, EASYPROPHY 400
Device Name EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
Original Applicant
BEYES DENTAL CANADA INC
3500 south dupont highway
dover,  DE  19901
Original Contact anthony hopkins
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/30/2011
Decision Date 12/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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