FDA 510(k) Application Details - K070019

Device Classification Name Powder, Porcelain

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510(K) Number K070019
Device Name Powder, Porcelain
Applicant DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK, PA 17404 US
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Contact HELEN LEWIS
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 01/03/2007
Decision Date 01/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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