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Sign in to claim this brandHangzhou SHINING3D Dental Technology Co., Ltd.
China·CN-MF-000033456
Last updated May 23, 2026
What Hangzhou SHINING3D Dental Technology Co., Ltd. makes
The company produces dental resin materials and systems for fabricating appliances, including stereolithography (SLA) and digital light processing (DLP) printing solutions. These materials are designed for creating dental restorations, models, and orthodontic devices, supporting computer-aided design and manufacturing (CAD/CAM) workflows in dental laboratories and clinics.
The portfolio includes devices classified as Class I, Class II, and Class IIa under global regulatory frameworks. These products are registered in the EU’s EUDAMED database, the FDA’s 510(k) and UDI systems in the United States, and are manufactured in China.
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 Hangzhou SHINING3D Dental Technology Co., Ltd. manufacture?
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.
Where is Hangzhou SHINING3D Dental Technology Co., Ltd. based?
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.
In which regulatory registries are Hangzhou SHINING3D Dental Technology Co., Ltd.’s devices listed?
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.
How are Hangzhou SHINING3D Dental Technology Co., Ltd.’s dental devices classified under global regulations?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou, Zhejiang,China, China, China
- Website
- shining3d.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mei Wang
- EUDAMED SRN
- CN-MF-000033456
- FDA FEI Number
- —
- DUNS Number
- 406871432
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cx100-A2 | 0950 | EUDAMED | Class I | Active |
| Cb11 A3.5 | 0721 | EUDAMED | Class IIa | Active |
| Cx100-B1 | 0967 | EUDAMED | Class I | Active |
| Cb11 B1 | 0738 | EUDAMED | Class IIa | Active |
| Cx100-A1 | 0943 | EUDAMED | Class I | Active |
| Cb11 B3 | 0752 | EUDAMED | Class IIa | Active |
| Cb11 A3 | 0714 | EUDAMED | Class IIa | Active |
| Cb11 B2 | 0745 | EUDAMED | Class IIa | Active |
| Cb11 A2 | 0707 | EUDAMED | Class IIa | Active |
| Cx100-Bl | 0974 | EUDAMED | Class I | Active |
| Shining 3d® | CB20-B1 | FDA UDI | Class II | Active |
| Shining 3d® | CB11-B2 | FDA UDI | Class II | Active |
| Shining 3d® | CB11-B1 | FDA UDI | Class II | Active |
| Shining 3d® | Ortho Model Resin OD02 | FDA UDI | Class I | Active |
| Shining 3d® | W20 | FDA UDI | Class I | Active |
| Shining 3d® | CB20-A3 | FDA UDI | Class II | Active |
| Shining 3d® | CB20-A3.5 | FDA UDI | Class II | Active |
| Shining 3d® | DT20-LT | FDA UDI | Class II | Active |
| Shining 3d® | CB11-A1 | FDA UDI | Class II | Active |
| Shining 3d® | DT20-LRP | FDA UDI | Class II | Active |
| Shining 3d® | DT20-OR | FDA UDI | Class II | Active |
| Shining 3d® | CB20-A1 | FDA UDI | Class II | Active |
| Shining 3d® | CB11-A2 | FDA UDI | Class II | Active |
| Shining 3d® | Surgical Guide Resin SG02 | FDA UDI | Class I | Active |
| Shining 3d® | CB11-A3 | FDA UDI | Class II | Active |
| Shining 3d® | DT01-LT | FDA UDI | Class I | Active |
| Shining 3d® | CB11-A3.5 | FDA UDI | Class II | Active |
| Shining 3d® | CB20-A2 | FDA UDI | Class II | Active |
| Shining 3d® | CB20-B2 | FDA UDI | Class II | Active |
| Shining 3d® | DT01-LRP | FDA UDI | Class I | Active |
| Shining 3d® | DT01-OR | FDA UDI | Class I | Active |
| Shining 3d® | CB20-B3 | FDA UDI | Class II | Active |
| Shining 3d® | Dental Model Resin DM12 | FDA UDI | Class I | Active |
| Shining 3d® | CB11-B3 | FDA UDI | Class II | Active |
| Shining 3d® | Dental Model Resin DM03 | FDA UDI | Class I | Active |
| Tn11-B3 | 0592 | EUDAMEDFDA UDI | Class I | Active |
| Tn11-B2 | 0585 | EUDAMEDFDA UDI | Class I | Active |
| Tn11-A3.5 | 0561 | EUDAMEDFDA UDI | Class I | Active |
| LumiCera | K260170 | FDA 510(k) | Class II | Active |
| Denture Base Resin DT20 | K250946 | FDA 510(k) | Class II | Active |
| Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | K253053 | FDA 510(k) | Class II | Active |
| Dura-Arch | K261261 | FDA 510(k) | Class II | Active |
| Dura-Crown | K261356 | FDA 510(k) | Class II | Active |
| Sh01 | 0202 | EUDAMEDFDA UDI | Class I | Active |
| Tn11-B1 | 0578 | EUDAMEDFDA UDI | Class I | Active |
| Tn11-A2 | 0547 | EUDAMEDFDA UDI | Class I | Active |
| Tn11-A1 | 0127 | EUDAMEDFDA UDI | Class I | Active |
| Dt02-Or | 0516 | EUDAMED | Class I | Active |
| Surgical Guide Resin SG01 1kg/bottle | 0042 | EUDAMED | Class I | Active |
| Ss01 | 0158 | EUDAMEDFDA UDI | Class I | Active |
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