FDA 510(k) Application Details - K063659

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K063659
Device Name Activator, Ultraviolet, For Polymerization
Applicant DENT CORP. RESEARCH & DEVELOPMENT
7-11 SOUTH BROADWAY
WHITE PLAINS, NY 10601 US
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Contact DAVID ALBELDA
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 12/08/2006
Decision Date 04/30/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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