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Sign in to claim this brandHuge Dental Material Co., Ltd.
US
Last updated May 23, 2026
What Huge Dental Material Co., Ltd. makes
Huge Dental Material Co., Ltd. manufactures resin artificial teeth and temporary dental crowns/bridges, including synthetic polymer teeth and polymethyl methacrylate (PMMA) blocks for dental restorations.
Their products are classified as Class II devices and are authorised through FDA pathways, including 510(k) and UDI registrations. The company 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 medical devices does Huge Dental Material Co., Ltd. manufacture?
Huge Dental Material Co., Ltd. specialises in dental restorative devices, specifically resin artificial teeth and temporary dental crowns/bridges. Their product line includes synthetic polymer teeth and polymethyl methacrylate (PMMA) blocks, which are used in dental laboratories to fabricate custom restorations for patients.
Where is Huge Dental Material Co., Ltd. based?
The company is headquartered in the United States, where it designs, develops, and manufactures its dental materials and devices.
Which regulatory registries or databases list Huge Dental Material Co., Ltd.’s devices?
Huge Dental Material Co., Ltd.’s devices are authorised through the U.S. Food and Drug Administration (FDA) pathways, including the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with FDA requirements for Class II devices.
How are Huge Dental Material Co., Ltd.’s devices classified under FDA regulations?
All of Huge Dental Material Co., Ltd.’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness.
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
- 420283541
Catalogue (94)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Synthetic Polymer Teeth | Acrylic Shell | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | Acrylic Shell | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIPLUS | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIJING | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | MAIST | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIJING | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAILI | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIPLUS | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | BLUEBELL | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | Acrylic Teeth Shade Guide-Two layers | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | SONNING | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | SONNING | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | SONNING | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | Acrylic Teeth Shade Guide-Two layers | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | Acrylic Teeth Shade Guide-MAIST | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAITONG | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | IMPLA | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | IMPLA | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIPLUS | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Pmma Block | Multilayer | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIPLUS | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIFENG | FDA UDI | Class II | Active |
| Pmma Block | Clear | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | MAIST | FDA UDI | Class II | Active |
| Pmma Block | Monolayer | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAILI | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIFENG | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAITONG | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAIFENG | FDA UDI | Class II | Active |
| Synthetic Polymer Teeth | KAILI | FDA UDI | Class II | Active |
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