Changshu Shangchi Dental Materials Co., Ltd.

Changshu Shangchi Dental Materials Co., Ltd. specializes in dental materials used primarily in prosthetics and restorative procedures. Their portfolio includes dental casting non-noble alloys—used for creating durable dental restorations—and dental base plate materials, such as wax formulations. These products are designed for dental laboratories to create temporary molds and casts during the fabrication of dental appliances like crowns, bridges, or dentures.

Changshu Shangchi Dental Materials Co., Ltd. has a presence in the United States, though its headquarters or primary operations are based in China. The company’s dental materials, including its alloys and wax products, are distributed and used in the U.S. market for dental laboratory applications.

Devices produced by Changshu Shangchi Dental Materials Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and identification of their dental casting alloys and base plate materials, which are classified under regulatory frameworks as either Class I or Class II devices.

The company’s dental devices are classified under the FDA’s regulatory system as either Class I or Class II. Class I devices generally pose minimal risk and require less stringent controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, as outlined in the FDA’s device classification system.