FDA 510(k) Application Details - K012849

Device Classification Name Post, Root Canal

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510(K) Number K012849
Device Name Post, Root Canal
Applicant J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT
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Regulation Number 872.3810

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Classification Product Code ELR
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Date Received 08/03/2001
Decision Date 03/27/2002
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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