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FDA 510(k) Application Details - K102844
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K102844
Device Name
Agent, Tooth Bonding, Resin
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact
Michelle Schiltz-Taing
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Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
09/29/2010
Decision Date
10/29/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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