Material, Tooth Shade, Resin

Bioden Co., Ltd

The following data is part of a premarket notification filed by Bioden Co., Ltd with the FDA for Zircos-com.

Pre-market Notification Details

Device IDK190139
510k NumberK190139
Device Name:Zircos-Com
ClassificationMaterial, Tooth Shade, Resin
Applicant Bioden Co., Ltd #B-803 119, Gasan Digital 1-ro, Geumcheon-gu Seoul,  KR 08589
ContactKim Hye Min
CorrespondentChris Park
Med.com 1809 Holland Dr Somerset,  NJ  08873
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-29
Decision Date2020-04-24

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