Data / Medical devices / China / Hangzhou Shining3d Dental Technology Co., Ltd
Hangzhou Shining3d Dental Technology Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 5 510(k) clearances
Hangzhou Shining3d Dental Technology Co., Ltd is registered with the FDA (registration 3026312357) in Hangzhou Zhejiang, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 27, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3026312357
- Address
- 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou Zhejiang, China, 311258
- Owner or operator
- Hangzhou SHINING3D Dental Technology Co., Ltd (10086991)
- Roles
- Manufacturer
- First device listed
- December 29, 2022
- Registered through
- 2027
- Brand names listed
- CB11-A1, CB11-A2, CB11-A3, CB11-A3.5, CB11-B1, CB11-B2, CB11-B3, CX100-A1, CX100-A2, CX100-B1, CX100-BL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | K261356 | Dura-Crown | EBF | Substantially Equivalent | Hangzhou SHINING3D Dental Technology Co., Ltd. | accessdata.fda.gov |
| April 17, 2026 | K261261 | Dura-Arch | EBG | Substantially Equivalent | Hangzhou SHINING3D Dental Technology Co., Ltd. | accessdata.fda.gov |
| January 21, 2026 | K260170 | LumiCera | EBF | Substantially Equivalent | Hangzhou SHINING3D Dental Technology Co., Ltd. | accessdata.fda.gov |
| September 23, 2025 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | EBF | Substantially Equivalent | Hangzhou SHINING3D Dental Technology Co., Ltd. | accessdata.fda.gov |
| March 31, 2025 | K250946 | Denture Base Resin DT20 | EBI | Substantially Equivalent | Hangzhou SHINING3D Dental Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Impression Tray, Resin
Updated April 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.