HySil Plus Impression Materials

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 Hysil Plus Impression Materials.

Pre-market Notification Details

Device IDK210041
510k NumberK210041
Device Name:HySil Plus Impression Materials
ClassificationMaterial, Impression
Applicant Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan,  KR 48002
ContactJinwoo Bae
CorrespondentPeter Lee
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 Received2021-01-07
Decision Date2021-03-18

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