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FDA 510(k) Application Details - K172106
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K172106
Device Name
Agent, Tooth Bonding, 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
872.3200
More FDA Info for this Regulation Number
Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/12/2017
Decision Date
08/31/2017
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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