FDA applicant
Premium Plus (Dongguan) Limited
FDA records 3 decisions for Premium Plus (Dongguan) Limited (Dongguan, CN) from 2022 to 2025: 3 510(k) clearances. Most are in product codes EGS (Handpiece, Contra- And Right-Angle Attachment…) and PEM (Dental Barriers And Sleeves). Its devices cite 3 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 Premium Plus (Dongguan) Limited’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 2022.
Planning a device like Premium Plus (Dongguan) Limited’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 “Premium”
FDA records each applicant name separately; these may or may not be the same firm.