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FDA 510(k) Application Details - K133836
Device Classification Name
Coating, Filling Material, Resin
More FDA Info for this Device
510(K) Number
K133836
Device Name
Coating, Filling Material, Resin
Applicant
GC AMERICA INC.
3737 W. 127TH STREET
ALSIP, IL 60803 US
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Contact
MARK HEISS
Other 510(k) Applications for this Contact
Regulation Number
872.3310
More FDA Info for this Regulation Number
Classification Product Code
EBD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2013
Decision Date
03/06/2014
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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