Is this your brand? Sign in to claim ownership.
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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 694821663
Catalogue (2760)
Page 7 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Razor / MegaPlus | W 1100 A3 22 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 A2 28 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Gray x1 15ml | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 B4 22 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML AT A3 16 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT A4 98 * 22T | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT D2 30 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1100 A4 B55 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT BL0 30 | FDA UDI | Class II | Active |
| Chang's DA-vich | Deep Dentin B Lite 40ml | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT C4 28 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT A2 98 * 18T | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT A3.5 98 * 20T | FDA UDI | Class II | Active |
| LavaStone | W LS A2 22 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 C4 28 | FDA UDI | Class II | Active |
| BlueTooth | Z BT A3 12 | FDA UDI | Class II | Active |
| Everest / MegaPlus | D 1300 A3 18 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1300 A4 B40 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 D3 28 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | Z ML AT A3.5 25 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1300 B3 18 | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 800 A0 20 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 C3 30 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 B2 20 | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 1300 A1 B55 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT C3 28 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT D3 98 * 18T | FDA UDI | Class II | Active |
| Razor / MegaPlus | C 800 A4 B40 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ BL3 12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ D4 14 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT D2 16 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT D3 98 * 30T | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 Dark 22 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT B3 25 | FDA UDI | Class II | Active |
| Universal Speed | W ML UVS C4 14 | FDA UDI | Class II | Active |
| LavaStone | W LS A2 10 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block AT D4 98 * 12T | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1300 B4 12 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT A2 98 * 16T | FDA UDI | Class II | Active |
| Everest / MegaPlus | D 1300 A1 14 | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 800 A0 12 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT C2 16 | FDA UDI | Class II | Active |
| Chang's DA-vich | Effect Orange 15ml | FDA UDI | Class II | Active |
| Chang's DA-vich | Dipping C4 100ml | FDA UDI | Class II | Active |
| Everest / MegaPlus | Z 1100 A0 25 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT C1 98 * 12T | FDA UDI | Class II | Active |
| Razor / MegaPlus | W 1100 XA1 25 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML PT D2 25 | FDA UDI | Class II | Active |
| Everest / Megabio Rainbow | W ML AT+ B2 20 | FDA UDI | Class II | Active |
| R2iCE | R2iCE Zirconia Block PT D2 98 * 12T | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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