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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, tooth shade, resin
510(k) Number K121583
Device Name CLEARFIL MAJESTY FLOW
Original Applicant
KURARAY NORITAKE DENTAL INC.
33 maiden lane, 6th floor
new york,  NY  10038
Original Contact kiyoyuki arikawa
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/30/2012
Decision Date 07/25/2012
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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