FDA applicant
Rizhao Huge Biomaterials Company, Ltd.
FDA records 13 decisions for Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN) from 2020 to 2025: 13 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 15 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 Rizhao Huge Biomaterials Company, 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 2020.
Planning a device like Rizhao Huge Biomaterials Company, 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) ReportOther applicant names beginning “Rizhao”
FDA records each applicant name separately; these may or may not be the same firm.