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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K120159
Device Name BEAUTICEM SA
Original Applicant
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos,  CA  92078
Original Contact david p morais
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/19/2012
Decision Date 06/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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