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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
Original Applicant
PRIME DENTAL MANUFACTURING, INC.
4555 west addison street
chicago,  IL  60641
Original 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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