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DONGGUAN XIANGTONG CO., LTD

US

Last updated May 23, 2026

What DONGGUAN XIANGTONG CO., LTD makes

The company produces ceramic materials for dental appliance fabrication and dye for dental prostheses, alongside non-noble alloys used in dental casting. Their portfolio includes the XTCERA brand, which appears to cover multiple ceramic-based dental applications.

These products are classified as Class II medical devices and are authorised via FDA 510(k) and UDI registrations. The company 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 Dongguan Xiangtong Co., Ltd produce?

Dongguan Xiangtong Co., Ltd specializes in dental-focused medical devices, including ceramic materials for dental appliance fabrication, dye for dental prostheses, and non-noble alloys used in dental casting. Their product line primarily serves applications in restorative and prosthetic dentistry, such as crowns, bridges, or other fixed dental restorations.

Where is Dongguan Xiangtong Co., Ltd based?

The company is based in the United States. While the name suggests a location in China, the provided data confirms its operational headquarters and regulatory filings are associated with the US market.

Which regulatory registries list the company’s devices?

The company’s devices are listed under the FDA’s 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance for Class II devices in the US market.

How are the company’s devices classified under medical device regulations?

The company’s products fall under Class II medical device classification, which typically requires special controls beyond general controls to ensure safety and effectiveness. This classification is common for dental devices that pose moderate risk, such as prostheses or casting alloys.

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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LinkedIn
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Facebook
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Email
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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
544441227

Catalogue (174)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
Xtcera XT-E 98*22
FDA UDI
Class IIActive
X-Sinter XW98*14
FDA UDI
Class IIActive
Xtcera XT-E 98*18
FDA UDI
Class IIActive
Xtcera XT-E 98*12
FDA UDI
Class IIActive
Xtcera XT-E 98*18
FDA UDI
Class IIActive
Xtcera XW98*18
FDA UDI
Class IIActive
Xtcera XT-E 98*22
FDA UDI
Class IIActive
Xtcera XT-E 98*25
FDA UDI
Class IIActive
Xtcera 0M3
FDA UDI
Class IIActive
Xtcera A3
FDA UDI
Class IIActive
Xtcera B4
FDA UDI
Class IIActive
X-Sinter XW98*20
FDA UDI
Class IIActive
Xtcera XT-E 98*20
FDA UDI
Class IIActive
Xtcera XT-E 98*22
FDA UDI
Class IIActive
Xtcera XT-E 98*10
FDA UDI
Class IIActive
Xtcera XW98*20
FDA UDI
Class IIActive
Xtcera XT-E 98*14
FDA UDI
Class IIActive
Xtcera XT-E 98*16
FDA UDI
Class IIActive
Xtcera XW98*18
FDA UDI
Class IIActive
Xtcera XW98*25
FDA UDI
Class IIActive
Xtcera XT-E 98*12
FDA UDI
Class IIActive
Xtcera C1
FDA UDI
Class IIActive
Coloring Liquid K220017
FDA 510(k)
Class IIActive
X-cera Pre-shaded Zirconia Blanks K202673
FDA 510(k)
Class IIActive

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