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U&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
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LinkedIn
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Facebook
—
Email
—
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 8 of 56
DeviceModel / ReferenceRegistriesClassStatus
Razor / MegaPlus W 800 D3 28
FDA UDI
Class IIActive
Everest W ML UV A3 18
FDA UDI
Class IIActive
Razor / MegaPlus W 1300 A3.5 20
FDA UDI
Class IIActive
Everest / MegaPlus W ML PT A1 16
FDA UDI
Class IIActive
U&C Liquid U&C Natural B4 30ml
FDA UDI
Class IIActive
Chang's DA-vich Dipping C2 100ml
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block AT B4 98 * 28T
FDA UDI
Class IIActive
Razor / MegaPlus W 1100 BL1 20
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML AT BL2 12
FDA UDI
Class IIActive
Universal Speed W ML UVS C3 20
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block PT B1 98 * 20T
FDA UDI
Class IIActive
Razor / MegaPlus W 1100 C1 25
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML AT+ B3 28
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block AT A4 98 * 18T
FDA UDI
Class IIActive
Everest / MegaPlus D 1100 A0 25
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block PT C1 98 * 22T
FDA UDI
Class IIActive
Chang's DA-vich Dentin B1 100ml
FDA UDI
Class IIActive
Everest / Megabio Rainbow Z ML AT A3 28
FDA UDI
Class IIActive
Everest / MegaPlus W 1300 A3 28
FDA UDI
Class IIActive
Everest / MegaPlus W ML PT A2 20
FDA UDI
Class IIActive
Everest / MegaPlus Z 800 A3 25
FDA UDI
Class IIActive
Everest / MegaPlus 5183 LT WH 98-14
FDA UDI
Class IIActive
Razor / MegaPlus Z 800 Light 14
FDA UDI
Class IIActive
Razor / MegaPlus C 800 A0 B55
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML AT+ C1 16
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML PT B1 14
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML AT B1 22
FDA UDI
Class IIActive
Everest / MegaPlus Z 800 A3 18
FDA UDI
Class IIActive
Everest / MegaPlus Z 1300 A4 16
FDA UDI
Class IIActive
Everest / MegaPlus 5162 HT WH 98-12
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block PT A1 98 * 12T
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML AT+ BL1 20
FDA UDI
Class IIActive
Razor / MegaPlus W 1300 C4 25
FDA UDI
Class IIActive
Razor / MegaPlus W 800 B3 14
FDA UDI
Class IIActive
Razor / MegaPlus W 800 A0 28
FDA UDI
Class IIActive
Everest W MO A3 25
FDA UDI
Class IIActive
Razor / MegaPlus W 1300 A0 22
FDA UDI
Class IIActive
Everest / MegaPlus Z 800 ML 25
FDA UDI
Class IIActive
Everest / Megabio Rainbow W ML PT BL1 28
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block PT D4 98 * 14T
FDA UDI
Class IIActive
Chang's DA-vich Deep Dentin A Lite 40ml
FDA UDI
Class IIActive
BlueTooth Z BT A2 28
FDA UDI
Class IIActive
Razor / MegaPlus C 1100 A3 B55
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block AT B3 98 * 14T
FDA UDI
Class IIActive
Chang's DA-vich Dentin C4 40ml
FDA UDI
Class IIActive
Everest / MegaPlus D 1100 A4 25
FDA UDI
Class IIActive
R2iCE R2iCE Zirconia Block PT C3 98 * 30T
FDA UDI
Class IIActive
U&C Liquid U&C Natural A3.5 30ml
FDA UDI
Class IIActive
Everest / MegaPlus 5184 LT WH 98-16
FDA UDI
Class IIActive
Razor / MegaPlus W 800 D3 30
FDA UDI
Class IIActive

Related Companies

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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