FDA applicant
Longly Biotechnology (Wuhan) Co., Ltd.
FDA records 2 decisions for Longly Biotechnology (Wuhan) Co., Ltd. (Wuhan, CN) in 2024: 2 510(k) clearances. All are in product code KIF (Resin, Root Canal Filling). 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 Longly Biotechnology (Wuhan) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Longly Biotechnology (Wuhan) 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