ROSA Bracket

Bracket, Ceramic, Orthodontic


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

Pre-market Notification Details

Device IDK182672
501k NumberK182672
Device Name:ROSA 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 Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang,  KR 14067
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-26
Decision Date2019-11-15

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