FDA 510(k) Application Details - K062289

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K062289
Device Name Activator, Ultraviolet, For Polymerization
Applicant BONART CO. LTD.
398 S. LEMON CREEK DR.
STE. L
WALNUT, CA 91789 US
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Contact ERIC L ONG
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 08/07/2006
Decision Date 01/03/2007
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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