Hangzhou SHINING3D Dental Technology Co., Ltd.

Hangzhou SHINING3D Dental Technology Co., Ltd. specializes in dental appliance fabrication materials, specifically resins used in stereolithography (SLA) and digital light processing (DLP) printing technologies. These resins are primarily designed for creating dental restorations, models, and orthodontic devices, enabling computer-aided design and manufacturing (CAD/CAM) workflows in dental labs and clinics.

The company is based in China, as indicated by its country designation. While the exact location within China is not specified, this information reflects its operational headquarters or primary manufacturing presence.

The company’s devices appear in multiple regulatory databases, including the EU’s EUDAMED system, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database in the United States. These listings reflect compliance tracking for devices classified under EU and U.S. regulatory frameworks.

The company’s dental resin materials and systems are classified under Class I, Class II, and Class IIa categories in global regulatory systems. Class I devices generally pose minimal risk, while Class II and Class IIa devices require additional scrutiny due to moderate risks (e.g., patient safety implications in dental applications). Classification depends on factors like intended use, potential harm, and manufacturing controls.