Osstem Abutment System

Abutment, Implant, Dental, Endosseous

Osstem Implant Co., Ltd.

The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Osstem Abutment System.

Pre-market Notification Details

Device IDK221684
510k NumberK221684
Device Name:Osstem Abutment System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan,  KR 48002
ContactSeungju Kang
CorrespondentPeter Lee
HiOSSEN Inc. 85 Ben Fairless Drive Fairless Hills,  PA  19030
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-10
Decision Date2022-09-08

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