FDA applicant
Spident Co., Ltd.
FDA records 22 decisions for Spident Co., Ltd. (Incheon, KR) from 2009 to 2026: 22 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 20 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 Spident Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Spident Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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