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FDA 510(k) Application Details - K142886
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K142886
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
DANVILLE MATERIALS, LLC.
3420 Fostoria Way Ste A200
SAN RAMON, CA 94583 US
Other 510(k) Applications for this Company
Contact
Dong Hua
Other 510(k) Applications for this Contact
Regulation Number
872.3750
More FDA Info for this Regulation Number
Classification Product Code
DYH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/02/2014
Decision Date
03/18/2015
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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