FDA applicant
Osstem Implant Co., Ltd.
FDA records 68 decisions for Osstem Implant Co., Ltd. (Busan, KR) from 2006 to 2026: 68 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 158 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 149 predicates, 104 of them its own earlier devices. 9 recalls are 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.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
9in 2025
Class I Class II/III not classified
Planning a device like Osstem Implant 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) ReportOther applicant names beginning “Osstem”
FDA records each applicant name separately; these may or may not be the same firm.