HG II SHORT FIXTURE SYSTEM

Implant, Endosseous, Root-form

OSSTEM IMPLANT CO.,LTD

The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Hg Ii Short Fixture System.

Pre-market Notification Details

Device IDK091678
510k NumberK091678
Device Name:HG II SHORT FIXTURE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
ContactPatrick Lim
CorrespondentPatrick Lim
OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-10
Decision Date2010-02-18

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