FDA 510(k) Application Details - K031615

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K031615
Device Name Activator, Ultraviolet, For Polymerization
Applicant DENTSPLY INTERNATIONAL
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 05/23/2003
Decision Date 07/21/2003
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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