LED Curing Light

Activator, Ultraviolet, For Polymerization

MONITEX INDUSTRIAL CO., LTD.

The following data is part of a premarket notification filed by Monitex Industrial Co., Ltd. with the FDA for Led Curing Light.

Pre-market Notification Details

Device IDK161855
510k NumberK161855
Device Name:LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
Applicant MONITEX INDUSTRIAL CO., LTD. 6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. New Taipei City,  TW 241-58
ContactShu-lung Wang
CorrespondentShu-lung Wang
MONITEX INDUSTRIAL CO., LTD. 6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. New Taipei City,  TW 241-58
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-06
Decision Date2017-11-27

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