K3

Unit, Operative Dental

Osstem Implant Co., Ltd.

The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for K3.

Pre-market Notification Details

Device IDK183347
510k NumberK183347
Device Name:K3
ClassificationUnit, Operative Dental
Applicant Osstem Implant Co., Ltd. 1st Floor, B-dong, 135 Gasan Digital 2-ro, Geumcheon-gu Seoul,  KR 08504
ContactHyeri Han
CorrespondentPeter Lee
Hiossen Inc. 85 Ben Fairless Dr Pennsylvania,  PA  19030
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-03
Decision Date2019-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800000995052 K183347 000
08800000995045 K183347 000

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