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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K161891
Device Name HC Primer
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 Number872.3200
Classification Product Code
KLE  
Date Received07/11/2016
Decision Date 11/21/2016
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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