FDA 510(k) Application Details - K963110

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K963110
Device Name Activator, Ultraviolet, For Polymerization
Applicant J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON, DC 20005 US
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Contact TERRY G MAHN
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 08/12/1996
Decision Date 10/24/1996
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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