LED Curing Light

Activator, Ultraviolet, For Polymerization

Foshan CICADA Dental Instrument Co., Ltd.

The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co., Ltd. with the FDA for Led Curing Light.

Pre-market Notification Details

Device IDK192233
510k NumberK192233
Device Name:LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
Applicant Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base Shihan Town, Nanhai Foshan,  CN
ContactJuan Liu
CorrespondentJet Li
KEDA Biological Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-02-13

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