VENUS Bracket, ROSE Bracket

Bracket, Ceramic, Orthodontic


The following data is part of a premarket notification filed by Gni Co., Ltd with the FDA for Venus Bracket, Rose Bracket.

Pre-market Notification Details

Device IDK201410
510k NumberK201410
Device Name:VENUS Bracket, ROSE Bracket
ClassificationBracket, Ceramic, Orthodontic
Applicant GNI Co., LTD 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong,  KR 18469
ContactDuk Soo Kim
CorrespondentSang Hwa Myung
E&M D-1474ho, 230 Simin-daero, Dongan-gu Anyang,  KR 14067
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2021-03-12

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