# Shandong Huge Dental Material Corporation

- Location (FDA's records): Rizhao City, CN
- FDA decisions: 9 (2016–2026): 9 510(k) clearances
- Product codes: EBI (3), EMA (2), EIH (1), MQC (1), NXC (1), ELW (1)
- 510(k) review time since 2016: median 100 days, against 154 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 1 (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
- Vertex-Dental B.V.: 2 (https://510kreport.com/company/vertex-dental)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Perflex: 1 (https://510kreport.com/company/perflex)
- Liaoning Upcera Co., Ltd.: 1 (https://510kreport.com/company/liaoning-upcera)
- Astron Dental Corp.: 1 (https://510kreport.com/company/astron-dental)
- Zhermack S.P.A.: 1 (https://510kreport.com/company/zhermack)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- Sprintray, Inc.: 1 (https://510kreport.com/company/sprintray)

## Firms that cite its devices most
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)

## Its most-cited devices
- K213994: Flexible Block (2022), cited by 1

## Recent decisions
- K260376: Denture Base (May 6, 2026)
- K260067: Eternal Art Porcelain Powders (Apr 9, 2026)
- K251252: NOBILCAM IMPAK Disc (Aug 1, 2025)
- K220680: Denture Base Polymers (Aug 12, 2022)
- K213994: Flexible Block (Mar 4, 2022)
- K201684: A-Silicone for Bite Registration (Sep 24, 2020)
- K181747: Orthodontic Appliance (Apr 18, 2019)
- K160345: Glass Ionomer Cement (Mar 3, 2017)

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