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FDA 510(k) Application Details - K181910
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K181910
Device Name
Agent, Tooth Bonding, Resin
Applicant
American Orthodontics
3524 Washington Avenue
Sheboygan, WI 53081 US
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Contact
Trang Adams
Other 510(k) Applications for this Contact
Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
07/17/2018
Decision Date
10/15/2018
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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