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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 K151700
Device Name BEAUTIFIL II Gingiva
Applicant
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact MAURO MALZYNER
Correspondent
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact MAURO MALZYNER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/24/2015
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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