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FDA 510(k) Application Details - K012729
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K012729
Device Name
Agent, Tooth Bonding, Resin
Applicant
KURARAY MEDICAL INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK, NY 10166 US
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Contact
MASAYA SASAKI
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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
08/14/2001
Decision Date
09/13/2001
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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