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FDA 510(k) Application Details - K123094
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
510(K) Number
K123094
Device Name
Bracket, Ceramic, Orthodontic
Applicant
TOMY, INC.
7046 OWL'S NEST TERRACE
BRADENTON, FL 34203 US
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Contact
CAROLYN PRIMUS
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Regulation Number
872.5470
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Classification Product Code
NJM
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More FDA Info for this Product Code
Date Received
10/02/2012
Decision Date
12/13/2012
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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