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Sign in to claim this brandU&C International Co., Ltd
US
Last updated May 23, 2026
What U&C International Co., Ltd makes
U&C International Co., Ltd manufactures ceramic materials used for dental appliance fabrication, including products like Everest/MegaPlus, Everest/Megabio Rainbow, Razor/MegaPlus, and R2iCE. These materials are designed for dental restorations and prosthetics, supporting custom dental appliances and crowns.
The company’s portfolio is classified under FDA’s Class II devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in 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 U&C International Co., Ltd manufacture?
U&C International Co., Ltd specializes in ceramic materials used for dental appliance fabrication. These materials are primarily designed for creating dental restorations and prosthetics, such as crowns and custom dental appliances. Examples include products like Everest/MegaPlus, Everest/Megabio Rainbow, Razor/MegaPlus, and R2iCE, which are all intended for use in dental laboratories and clinical settings.
Where is U&C International Co., Ltd based?
U&C International Co., Ltd is based in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices authorized in North America.
Which regulatory registries list U&C International Co., Ltd’s devices?
U&C International Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are U&C International Co., Ltd’s devices classified by regulatory authorities?
U&C International Co., Ltd’s devices fall under the FDA’s Class II classification. Class II devices are those that pose moderate risk and require special controls to ensure their safety and effectiveness, such as dental materials used in restorations, which require validation of performance and manufacturing processes.
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
- 694821663
Catalogue (2760)
Page 2 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Everest / MegaPlus | 5185 LT WH 98-18 | FDA UDI | Class II | Active |
| Everest | W ML UV A3.5 30 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ C2 20 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS C1 18 | FDA UDI | Class II | Active |
| Chang's DA-vich | Dentin C1 40ml | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 ML B65 | FDA UDI | Class II | Active |
| Everest / MegaPlus | 5174 LT A2 98-16 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W ML PT A3 18 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Fluorescence 15ml | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS A3.5 25 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS A4 30 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT A2 98 * 28T | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 A1 B55 | FDA UDI | Class II | Active |
| BlueTooth | W BT A3 12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT D2 12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ B2 30 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W ML PT B1 28 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT C3 98 * 12T | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML AT A4 12 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 B3 12 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1300 B2 30 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 800 A3 B40 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT B1 28 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 800 A2 14 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS B1 30 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML PT A4 10 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Orange-Y 40ml | FDA UDI | Class II | Active |
| Chang's DA-vich | Dentin C3 40ml | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML PT A3 18 | FDA UDI | Class II | Active |
| Everest / MegaPlus | 5172 LT A2 98-12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ C2 22 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1300 A4 B65 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 A1 B55 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 A0 14 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W MO A2 22 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 A3 14 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 A2 B55 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 B1 16 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 800 A3 B55 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 C3 25 | FDA UDI | Class II | Active |
| Razor / MegaPlus | D 800 Light 14 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS B1 16 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT C1 20 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W ML AT A4 16 | FDA UDI | Class II | Active |
| Everest / MegaPlus | D 800 A3 20 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT C3 20 | FDA UDI | Class II | Active |
| Chang's DA-vich | Dentin D2 100ml | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 C4 14 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1300 A2 22 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT B3 98 * 30T | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- U&C International Co., Ltd. Ansan-si Gyeonggi · KR FEI 3015108415