Question 1

What does Shenzhen Yurucheng Dental Materials Co., Ltd. make?

Accepted Answer

Shenzhen Yurucheng Dental Materials Co., Ltd. specializes in ceramic materials used for dental appliance fabrication, including products like YUCERA. These materials are designed for creating dental restorations and prosthetics such as crowns, bridges, and inlays using high-strength ceramic formulations. The company’s focus is on providing ceramic-based materials for dental laboratory applications.

Question 2

Where is Shenzhen Yurucheng Dental Materials Co., Ltd. based?

Accepted Answer

The manufacturer operates from the United States, as stated in the device data. Although the company name includes 'Shenzhen,' which is a city in China, the provided information explicitly identifies the country of operation as the US for regulatory listing purposes.

Question 3

Which regulatory registries list the devices made by Shenzhen Yurucheng Dental Materials Co., Ltd.?

Accepted Answer

The devices made by Shenzhen Yurucheng Dental Materials Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) system. This is indicated by the 'LISTED IN: fda_udi' field in the device data, meaning the products are included in the U.S. FDA’s UDI database for traceability and regulatory compliance.

Question 4

How are the devices made by Shenzhen Yurucheng Dental Materials Co., Ltd. classified?

Accepted Answer

The devices are classified as Class II, as specified in the 'DEVICE CLASSES: N' field, where 'N' corresponds to Class II under the FDA’s classification system. This classification reflects the risk level and regulatory controls applicable to dental ceramic materials used for restorations like crowns and bridges.

Device	Model / Reference	Registries	Class	Status
Yucera	ML-C4-SHT	FDA UDI	N	Unknown
Yucera	B3	FDA UDI	N	Unknown
Yucera	ML-A2-ST	FDA UDI	N	Unknown
Yucera	A3.5	FDA UDI	N	Unknown
Yucera	C3	FDA UDI	N	Unknown
Yucera	ML-BL2-4D	FDA UDI	N	Unknown
Yucera	White	FDA UDI	N	Active
Yucera	White	FDA UDI	N	Active
Yucera	ML-C4-UT	FDA UDI	N	Unknown
Yucera	C4	FDA UDI	N	Unknown
Yucera	0M3	FDA UDI	N	Unknown
Yucera	ML-C1-3D	FDA UDI	N	Unknown
Yucera	ML-D4-UT	FDA UDI	N	Unknown
Yucera	0M2	FDA UDI	N	Unknown
Yucera	ML-BL4-UT	FDA UDI	N	Unknown
Yucera	ML-BL4-3D	FDA UDI	N	Unknown
Yucera	C3	FDA UDI	N	Active
Yucera	A3	FDA UDI	N	Active
Yucera	A3	FDA UDI	N	Unknown
Yucera	A3.5	FDA UDI	N	Unknown
Yucera	C1	FDA UDI	N	Active
Yucera	A1	FDA UDI	N	Active
Yucera	ML-B4-3D	FDA UDI	N	Unknown
Yucera	D4	FDA UDI	N	Unknown
Yucera	A4	FDA UDI	N	Active
Yucera	ML-BL2-3D	FDA UDI	N	Unknown
Yucera	ML-A1-3D	FDA UDI	N	Unknown
Yucera	ML-BL1-UT	FDA UDI	N	Unknown
Yucera	ML-B4-3D	FDA UDI	N	Unknown
Yucera	B2	FDA UDI	N	Unknown
Yucera	B3	FDA UDI	N	Unknown
Yucera	0M1	FDA UDI	N	Unknown
Yucera	B1	FDA UDI	N	Unknown
Yucera	ML-0M2-3D	FDA UDI	N	Unknown
Yucera	White	FDA UDI	N	Unknown
Yucera	BL3	FDA UDI	N	Unknown
Yucera	A4	FDA UDI	N	Active
Yucera	D4	FDA UDI	N	Unknown
Yucera	ML-B3-4D	FDA UDI	N	Unknown
Yucera	A3	FDA UDI	N	Unknown
Yucera	ML-BL4-SHT	FDA UDI	N	Unknown
Yucera	ML-B4-UT	FDA UDI	N	Unknown
Yucera	ML-A1-SHT	FDA UDI	N	Unknown
Yucera	C2	FDA UDI	N	Active
Yucera	ML-A1-ST	FDA UDI	N	Unknown
Yucera	BL4	FDA UDI	N	Unknown
Yucera	A2	FDA UDI	N	Unknown
Yucera	0M2	FDA UDI	N	Unknown
Yucera	B1	FDA UDI	N	Unknown
Yucera	ML-0M3-UT	FDA UDI	N	Unknown

Shenzhen Yurucheng Dental Materials Co., Ltd.

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