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Sign in to claim this brandSHANDONG HUGE DENTAL MATERIAL CORPORATION
US
Last updated May 30, 2026
What SHANDONG HUGE DENTAL MATERIAL CORPORATION makes
The company manufactures dental materials and appliances, including preformed complete dentures, temporary crowns and bridges, reusable mouthguards, and silicone-based impression materials. Their portfolio also covers resin artificial teeth, ceramic fabrication materials for dental appliances, glass ionomer dental cement, and dental casting wax for restorative procedures.
These products are regulated under Class I, Class II, and unclassified (U) device categories in the FDA’s Unique Device Identification (UDI) system. The company’s devices are listed in the FDA’s UDI registry, adhering to U.S. medical device compliance requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Shandong Huge Dental Material Corporation manufacture?
Shandong Huge Dental Material Corporation specializes in dental materials and appliances, including preformed complete dentures, temporary dental crowns and bridges, reusable mouthguards, and silicone-based impression materials. Their portfolio also includes resin artificial teeth, ceramic fabrication materials for dental appliances, glass ionomer dental cement, and dental casting wax. These products are designed for restorative and protective dental procedures.
Where is Shandong Huge Dental Material Corporation based?
The company is based in the United States. This location influences its regulatory compliance, particularly with U.S. medical device requirements such as those enforced by the FDA.
Which regulatory registries list Shandong Huge Dental Material Corporation’s devices?
The company’s devices are listed in the FDA’s Unique Device Identification (UDI) registry. This registry ensures traceability and compliance with U.S. medical device regulations, helping healthcare providers and regulators verify product details.
How are Shandong Huge Dental Material Corporation’s devices classified under FDA regulations?
The company’s devices fall under three classification categories: Class I (generally low-risk), Class II (moderate-risk with special controls), and unclassified (U) devices. Classification depends on factors like the device’s intended use, potential risks, and regulatory requirements, ensuring appropriate oversight for patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 528184691
Catalogue (154)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elastomeric Impression Material | Type 0 (Putty Auto-Mix) | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | U | Active |
| Pmma Block | Clear | FDA UDI | U | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 0 (Bite Registration Dispenser-mix Normal Set) | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | IMPLA | FDA UDI | Class II | Active |
| Glass Ionomer Cement (Filling) | Filling I, Filling II | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIPLUS | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | U | Active |
| Synthetic Polymer Teeth | KAIFENG | FDA UDI | Class II | Active |
| Zirconia Block | HS | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIJING | FDA UDI | Class II | Active |
| Zirconia Block | MHT | FDA UDI | Class II | Active |
| Invisible Orthodontic Appliance | LX-A | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 0 (Bite Registration Dispenser-mix Normal Set) | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | U | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | BLUEBELL | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAITONG | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Active |
| Zirconia Block | AT | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Impression kit | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 1 (Heavy Body Dispenser-mix Fast Set) | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 1 (Heavy Body Dispenser-mix Fast Set) | FDA UDI | Class II | Active |
| Casting Wax | White | FDA UDI | Class I | Active |
| Pmma Block | Multilayer | FDA UDI | U | Active |
| A-Silicone for Bite Registration | Dispenser-mix Fast Set | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | U | Active |
| Pmma Block | Clear | FDA UDI | U | Active |
| Pmma Block | Multilayer | FDA UDI | U | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIFENG | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIJING | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | MAIST | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAILI | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 1 (Heavy Body Auto-mix Fast Set) | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Unknown |
| Synthetic Polymer Teeth | Acrylic Teeth Shade Guide-MAIST | FDA UDI | Class II | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Unknown |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | U | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix)+Type 3 (Light Body) | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | U | Active |
| Synthetic Polymer Teeth | BLUEBELL | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | U | Active |
| Synthetic Polymer Teeth | SONNING | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | U | Active |
| Elastomeric Impression Material | Type 0 (Putty Hand-Mix) | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | IMPLA | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | U | Active |
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