FDA 510(k) Application Details - K051203

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K051203
Device Name Activator, Ultraviolet, For Polymerization
Applicant MONITEX INDUSTRIAL CO., LTD.
6F, 70 GUANG-FU RD., SEC 1,
SAN-CHUNG CITY
TAIPEI 241-58 TW
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Contact SHU-LUNG WANG
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 05/11/2005
Decision Date 05/25/2005
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 Y
Expedited Review



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