# Huge Dental Material Co., Ltd.

- Location (FDA's records): Dover, DE
- FDA decisions: 2 (2010–2020): 2 510(k) clearances
- Product codes: ELM (1), EBG (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 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
- Xpdent Corp: 1 (https://510kreport.com/company/xpdent)
- Union Dental S.A./Unidesa.Odi: 1 (https://510kreport.com/company/union-dental-sa-unidesa-odi)
- Dental Vipi Ltda: 1 (https://510kreport.com/company/dental-vipi)
- Union Dental S.A.: 1 (https://510kreport.com/company/union-dental)

## Firms that cite its devices most
- Huliang (Shanghai) Bio-Tech Co., Ltd.: 1 (https://510kreport.com/company/huliang-shanghai-bio-tech)
- Wright Health Group, Ltd.: 1 (https://510kreport.com/company/wright-health-group)

## Its most-cited devices
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth (2010), cited by 1
- K201683: PMMA Block (2020), cited by 1

## Recent decisions
- K201683: PMMA Block (Nov 3, 2020)
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth (Aug 16, 2010)

Source page: https://510kreport.com/company/huge-dental-material