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FDA 510(k) Application Details - K112574
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K112574
Device Name
Cement, Dental
Applicant
PRIME DENTAL MANUFACTURING, INC.
4555 WEST ADDISON STREET
CHICAGO, IL 60641 US
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Contact
JAVIER ALVAREZ
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
09/06/2011
Decision Date
01/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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