# Rizhao Huge Biomaterials Company, Ltd.

- Location (FDA's records): Rizhao, CN
- FDA decisions: 13 (2020–2025): 13 510(k) clearances
- Product codes: EBF (4), KLE (4), EMA (3), EBG (1), EBC (1)
- 510(k) review time since 2016: median 96 days, against 102 for FDA's reviews in the same codes and years (6 of 12 faster)
- Predicates its devices cite: 15 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ivoclar Vivadent, Inc.: 4 (https://510kreport.com/company/ivoclar-vivadent)
- 3M Company: 3 (https://510kreport.com/company/3m)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Coltene/Whaledent, Inc.: 1 (https://510kreport.com/company/coltene-whaledent)
- Dmg USA, Inc.: 1 (https://510kreport.com/company/dmg-usa)
- 3M Espe AG Dental Products: 1 (https://510kreport.com/company/3m-espe-ag-dental-products)
- Liaoning Upcera Co., Ltd.: 1 (https://510kreport.com/company/liaoning-upcera)

## Firms that cite its devices most
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)

## Its most-cited devices
- K201790: Dual Cure Resin Cement (2020), cited by 2
- K202063: TrusFIL Universal Composite Restorative (2021), cited by 1

## Recent decisions
- K252785: TopCEM Vigor SA Self-Adhesive Resin Cement (Dec 12, 2025)
- K251271: TempFIT Temporary Crown and Bridge Resin (Jun 23, 2025)
- K242572: TopCEM-Try in Veneer Try-in Gel (Dec 20, 2024)
- K242530: HF-Etchant Hydrofluoric Acid Etching Gel (Dec 20, 2024)
- K242749: TopCEM Ceramic Primer Ceramic Coupling Agent (Nov 8, 2024)
- K241204: TopCEM-Veneer Light Cure Veneer Cement (Jun 28, 2024)
- K233082: TopCEM Dual Cure Resin Cement (Dec 22, 2023)
- K230455: Enamel Coating Resin (Jul 25, 2023)

Source page: https://510kreport.com/company/rizhao-huge-biomaterials