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FDA 510(k) Application Details - K203598
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K203598
Device Name
Material, Tooth Shade, Resin
Applicant
Tokuyama Dental Corporation
38-9 Taitou 1-chome
Taitou-ku 110-0016 JP
Other 510(k) Applications for this Company
Contact
Keith A. Baritt
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2020
Decision Date
02/03/2021
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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