FDA applicant
Osstem Implant Co., Ltd. Chair Business
FDA records 1 decision for Osstem Implant Co., Ltd. Chair Business (Ansan-Si, KR) in 2024: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). Its devices cite 1 predicate, 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 Osstem Implant Co., Ltd. Chair Business’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Osstem Implant Co., Ltd. Chair Business’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) ReportOther applicant names beginning “Osstem”
FDA records each applicant name separately; these may or may not be the same firm.