FDA applicant
Shenzhen Superline Technology CO., LTD.
FDA records 2 decisions for Shenzhen Superline Technology CO., LTD. (Shenzhen, CN) in 2025: 2 510(k) clearances. Most are in product codes EKX (Handpiece, Direct Drive, Ac-Powered) and LQY (Locator, Root Apex). 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 Shenzhen Superline Technology 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 2025.
Planning a device like Shenzhen Superline Technology 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