Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Rizhao Huge Biomaterials Company with 13 510(k) clearances. The most recent is a 510(k) clearance dated Dec 12, 2025: TopCEM Vigor SA Self-Adhesive Resin Cement.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 12, 2025 | TopCEM Vigor SA Self-Adhesive Resin CementK252785 · EMA | 510(k) clearances |
| Jun 23, 2025 | TempFIT Temporary Crown and Bridge ResinK251271 · EBG | 510(k) clearances |
| Dec 20, 2024 | HF-Etchant Hydrofluoric Acid Etching GelK242530 · KLE | 510(k) clearances |
| Dec 20, 2024 | TopCEM-Try in Veneer Try-in GelK242572 · EBF | 510(k) clearances |
| Nov 8, 2024 | TopCEM Ceramic Primer Ceramic Coupling AgentK242749 · KLE | 510(k) clearances |
| Jun 28, 2024 | TopCEM-Veneer Light Cure Veneer CementK241204 · EMA | 510(k) clearances |
| Dec 22, 2023 | TopCEM Dual Cure Resin CementK233082 · EBF | 510(k) clearances |
| Jul 25, 2023 | Enamel Coating ResinK230455 · EBC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
