Bright Bond Universal

Agent, Tooth Bonding, Resin

GENOSS Co., Ltd.

The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Bright Bond Universal.

Pre-market Notification Details

Device IDK200153
510k NumberK200153
Device Name:Bright Bond Universal
ClassificationAgent, Tooth Bonding, Resin
Applicant GENOSS Co., Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si,  KR 16229
ContactHong Jun Jeon
CorrespondentHong Jun Jeon
GENOSS Co., Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si,  KR 16229
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-22
Decision Date2020-10-28

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