Orthodontic Fixation Screw [Smart Anchor Miniscrew]

Implant, Endosseous, Orthodontic

GNI Co., LTD

The following data is part of a premarket notification filed by Gni Co., Ltd with the FDA for Orthodontic Fixation Screw [smart Anchor Miniscrew].

Pre-market Notification Details

Device IDK191041
510k NumberK191041
Device Name:Orthodontic Fixation Screw [Smart Anchor Miniscrew]
ClassificationImplant, Endosseous, 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 CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-19
Decision Date2020-08-28

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