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FDA 510(k) Application Details - K123826
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K123826
Device Name
Cement, Dental
Applicant
DFL INDUSTRIA E COMERCIO S.A.
18851 NE 29TH AVE 720
AVENTURE, FL 33180 US
Other 510(k) Applications for this Company
Contact
TARA CONRAD
Other 510(k) Applications for this Contact
Regulation Number
872.3275
More FDA Info for this Regulation Number
Classification Product Code
EMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2012
Decision Date
02/14/2013
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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