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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 10 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Everest / Megabio Rainbow | W ML AT D3 22 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W 800 A2 12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT A2 28 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 800 A0 22 | FDA UDI | Class II | Active |
| BlueTooth | Z BT A1 12 | FDA UDI | Class II | Active |
| U&C Liquid | U&C Effect Brown 50ml | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS B4 14 | FDA UDI | Class II | Active |
| Chang's DA-vich | Dentin B1 40ml | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS A1 10 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 ML B65 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT C4 98 * 25T | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML AT A4 22 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect V3 40ml | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 A4 12 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 800 A2 20 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS C3 22 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ C3 16 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1300 A1 14 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1300 A4 18 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT A3.5 98 * 28T | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT C4 98 * 22T | FDA UDI | Class II | Active |
| Everest | W ML UV A4 16 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1300 A3 12 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Incisal 15ml | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 800 A3 20 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT D4 18 | FDA UDI | Class II | Active |
| U&C Liquid | U&C Natural A3.5 100ml | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1300 ML 25 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W 800 A3 14 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT D2 98 * 20T | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT A3 98 * 20T | FDA UDI | Class II | Active |
| Razor / MegaPlus | Z 1100 BL1 25 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML AT A4 28 | FDA UDI | Class II | Active |
| LavaStone | W LS A1 30 | FDA UDI | Class II | Active |
| Zubler | W 1100 AA2 25 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT C4 98 * 16T | FDA UDI | Class II | Active |
| Razor | W CAP A0 14 | FDA UDI | Class II | Active |
| BlueTooth | W BT A3 18 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT B2 14 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT C4 98 * 30T | FDA UDI | Class II | Active |
| Razor / MegaPlus | Z 1100 BL2 35 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Osaka Gray 40ml | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1100 A1 22 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect White 15ml | FDA UDI | Class II | Active |
| Chang's DA-vich | Deep Dentin C Lite 15ml | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS BL1 28 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 A3.5 16 | FDA UDI | Class II | Active |
| Everest / MegaPlus | W ML PT A3 12 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 800 A4 B65 | FDA UDI | Class II | Active |
| BlueTooth | W BT A3 28 | 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