Non-Sterile Zirconia Block

Powder, Porcelain

Bioden Co., Ltd

The following data is part of a premarket notification filed by Bioden Co., Ltd with the FDA for Non-sterile Zirconia Block.

Pre-market Notification Details

Device IDK201492
510k NumberK201492
Device Name:Non-Sterile Zirconia Block
ClassificationPowder, Porcelain
Applicant Bioden Co., Ltd #B-803 119, Gasan Digital 1-ro, Geumcheon-gu, Korea Seoul,  KR
ContactMyeongeun Song
CorrespondentChris Park 1809 Holland Dr Somerset,  NJ  08873
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2021-03-10

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