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FDA 510(k) Application Details - K163568
Device Classification Name
Coating, Filling Material, Resin
More FDA Info for this Device
510(K) Number
K163568
Device Name
Coating, Filling Material, Resin
Applicant
Shofu Dental Corporation
1225 Stone Drive
San Marcos, CA 92078 US
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Contact
Mauro Malzyner
Other 510(k) Applications for this Contact
Regulation Number
872.3310
More FDA Info for this Regulation Number
Classification Product Code
EBD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2016
Decision Date
08/16/2017
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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