Cybird LED Curing Light

Activator, Ultraviolet, For Polymerization

DXM Co., Ltd

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

Pre-market Notification Details

Device IDK191221
510k NumberK191221
Device Name:Cybird LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
Applicant DXM Co., Ltd Baekseok-dong, Ilsan Technotown 1003, 138, Ilsan-ro, Ilsandong-gu Goyang-si,  KR 411-360
ContactSeung Hyun Kim
CorrespondentDave Kim
Mtech Group 8310 Buffalo Speedway Houston,  TX  77025
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-07
Decision Date2020-01-10

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