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FDA 510(k) Application Details - K160615
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
510(K) Number
K160615
Device Name
Bracket, Ceramic, Orthodontic
Applicant
TOMY, INC
6 TENKO BLG. 3-16-7
MIDORICHO, FUCHU CITY 183-0006 JP
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Contact
JINICHI WATANABE
Other 510(k) Applications for this Contact
Regulation Number
872.5470
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Classification Product Code
NJM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2016
Decision Date
08/26/2016
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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