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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 K112574
Device Name PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
Applicant
Prime Dental Manufacturing, Inc.
4555 W. Addison St.
Chicago,  IL  60641
Applicant Contact JAVIER ALVAREZ
Correspondent
Prime Dental Manufacturing, Inc.
4555 W. Addison St.
Chicago,  IL  60641
Correspondent Contact JAVIER ALVAREZ
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/06/2011
Decision Date 01/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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