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FDA 510(k) Application Details - K982164
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K982164
Device Name
Material, Tooth Shade, Resin
Applicant
KURARAY AMERICA, INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK, NY 10166 US
Other 510(k) Applications for this Company
Contact
KOJI FUJITA
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/19/1998
Decision Date
08/10/1998
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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