Hyflex Heavy, Hyflex Mono, Hyflex Light

Material, Impression

Osstem Implant Co., Ltd

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

Pre-market Notification Details

Device IDK151262
510k NumberK151262
Device Name:Hyflex Heavy, Hyflex Mono, Hyflex Light
ClassificationMaterial, Impression
Applicant Osstem Implant Co., Ltd 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan,  KR 612-070
ContactHeekwon Son
CorrespondentPatrick Lim
HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-13
Decision Date2015-09-21
Summary:summary

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