Magicore II System

Abutment, Implant, Dental, Endosseous

InnoBioSurg Co., Ltd.

The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore Ii System.

Pre-market Notification Details

Device IDK201621
510k NumberK201621
Device Name:Magicore II System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon,  KR 34027
ContactBo-yeon Lim
CorrespondentApril Lee
Withus Group Inc. 106 Superior Irvine,  CA  92620
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-07-15

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