Not currently registered with FDA under this name

Bioden Co., Ltd.

Seoul, South Korea. Named as applicant on 2 dental 510(k) clearances between 2020 and 2021. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22020–2021
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 2007–2026

510(k) clearances

Clearances on which FDA names Bioden Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
10 Mar 2021	K201492	Non-Sterile Zirconia Block	EIH Porcelain Powder
24 Apr 2020	K190139	Zircos-Com	EBF Resin Tooth Shade Material

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.