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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K122614
Device Name VINTAGE MP PRESS OVER
Original Applicant
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos,  CA  92078
Original Contact david p morais
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/27/2012
Decision Date 05/16/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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