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FDA 510(k) Application Details - K170986
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K170986
Device Name
Powder, Porcelain
Applicant
Kuraray Noritake Dental Inc.
Ote Center Bldg. 7F
Chiyoda-ku 100-0004 JP
Other 510(k) Applications for this Company
Contact
Yasujiro Ohara
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2017
Decision Date
07/13/2017
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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