Mei Ceramic Bracket

Bracket, Ceramic, Orthodontic

Orthosun Co., Ltd.

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

Pre-market Notification Details

Device IDK190608
501k NumberK190608
Device Name:Mei Ceramic Bracket
ClassificationBracket, Ceramic, Orthodontic
Applicant Orthosun Co., Ltd. 2F, 112, Pyeongni-gil, Gyeyang-gu Incheon,  KR 21008
ContactJu-sung Lee
CorrespondentPeter Chung
Plus Global 300 Atwood Street Pittsburgh,  PA  15213
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-11
Decision Date2019-11-04

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