GS 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 Gs Fixture System.

Pre-market Notification Details

Device IDK072896
510k NumberK072896
Device Name:GS FIXTURE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant OSSTEM IMPLANT CO.,LTD ONE BEN FAIRLESS DR. Fairless Hills,  PA  19030
ContactKim M Joo
CorrespondentKim M Joo
OSSTEM IMPLANT CO.,LTD ONE BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-11
Decision Date2007-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809917094933 K072896 000

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