FDA applicant
Bioden Co., Ltd.
FDA records 2 decisions for Bioden Co., Ltd. (Seoul, KR) from 2020 to 2021: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EIH (Powder, Porcelain). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bioden Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Bioden Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report