Premilled Titanium Block 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 Premilled Titanium Block System.

Pre-market Notification Details

Device IDK203344
510k NumberK203344
Device Name:Premilled Titanium Block System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon,  KR 34027
ContactSun-mi Park
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-13
Decision Date2021-08-25

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