FDA 510(k) Application Details - K111234

Device Classification Name Bracket, Ceramic, Orthodontic

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510(K) Number K111234
Device Name Bracket, Ceramic, Orthodontic
Applicant TP ORTHODONTICS, INC.
100 CENTER PLAZA
LA PORTE, IN 46350-0073 US
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Contact ROBIN INTAGLIATA
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Regulation Number 872.5470

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Classification Product Code NJM
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Date Received 05/02/2011
Decision Date 05/13/2011
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 Y
Expedited Review



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