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FDA 510(k) Application Details - K192992
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K192992
Device Name
Cement, Dental
Applicant
3M Deutschland GMBH
ESPE Platz, Seefeld
Bavaria 82229 DE
Other 510(k) Applications for this Company
Contact
Desi W. Soegiarto
Other 510(k) Applications for this Contact
Regulation Number
872.3275
More FDA Info for this Regulation Number
Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
10/25/2019
Decision Date
11/05/2019
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
Y
Expedited Review
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