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FDA 510(k) Application Details - K962885
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K962885
Device Name
Resin, Root Canal Filling
Applicant
BALADENT
1819 SOUTH MAY STREET, 2F
CHICAGO, IL 60608 US
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Contact
ROBERT W BAUER
Other 510(k) Applications for this Contact
Regulation Number
872.3820
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Classification Product Code
KIF
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More FDA Info for this Product Code
Date Received
07/24/1996
Decision Date
08/30/1996
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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