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FDA 510(k) Application Details - K092715
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K092715
Device Name
Resin, Root Canal Filling
Applicant
INNOVATIVE BIOCERAMIX INC.
1628 WEST 75TH AVE.
VANCOUVER, BC V6P 6G2 CA
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Contact
QUANZU YANG
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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
09/03/2009
Decision Date
09/28/2009
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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