FDA applicant
Simda Co., Ltd.
FDA records 3 decisions for Simda Co., Ltd. (Busan, KR) from 2023 to 2025: 3 510(k) clearances. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 146 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Simda 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
No recall linked to its devices since 2023.
Planning a device like Simda 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