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FDA 510(k) Application Details - K110508
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K110508
Device Name
Cement, Dental
Applicant
3M ESPE AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact
DESI W SOEGIARTO
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
02/22/2011
Decision Date
06/03/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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