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FDA 510(k) Application Details - K123348
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K123348
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA, IL 60143 US
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Contact
PAULA WENDLAND
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Regulation Number
872.3750
More FDA Info for this Regulation Number
Classification Product Code
DYH
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More FDA Info for this Product Code
Date Received
10/31/2012
Decision Date
02/28/2013
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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