HU/HS/HG PROSTHETIC 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 Hu/hs/hg Prosthetic System.

Pre-market Notification Details

Device IDK081575
510k NumberK081575
Device Name:HU/HS/HG PROSTHETIC SYSTEM
ClassificationAbutment, Implant, Dental, Endosseous
Applicant OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
ContactMinjoo Kim
CorrespondentMinjoo Kim
OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-05
Decision Date2008-09-02
Summary:summary

NIH GUDID Devices

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