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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 west addison street
chicago,  IL  60641
Contact javier alvarez
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/06/2011
Decision Date 01/23/2012
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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