FDA 510(k) Application Details - K033703

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K033703
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVENUE
P.O. BOX 872
YORK, PA 17405-0872 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 11/25/2003
Decision Date 02/06/2004
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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