FDA 510(k) Application Details - K051780

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K051780
Device Name Activator, Ultraviolet, For Polymerization
Applicant J. MORITA USA, INC.
9 MASON
IRVINE, CA 92618 US
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Contact HOWARD ROWE
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 07/01/2005
Decision Date 07/28/2005
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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