Hangzhou SHINING3D Dental Technology Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 7 device types, 7 products catalogued, 5 clearances.
Hangzhou SHINING3D Dental Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Material, Tooth Shade, Resin, Positioner, Tooth, Preformed and 5 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026312357 |
| FEI number | 3026312357 |
| DUNS | 406871432 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州先临齿科技术有限公司 |
|---|---|
| Unified social credit code | 91330109MA2B0TT20Q |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan |
| Postal code | 311258 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Surgical Guide Resin SG01; Surgical Guide Resin SG PRO; Surgical Guide Resin SG02 | 2022 | 70 |
| Additively Manufactured, Preformed, Resin Denture Tooth | Class 2 | Dura-Crown, Dura-Arch, CB11-A3, CB11-A1, CB11-B2, CB11-A3.5 and 4 more | 2023 | 10 |
| Crown And Bridge, Temporary, Resin | Class 2 | Dura-Crown, Dura-Arch, Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | 2025 | 13 |
| Material, Impression Tray, Resin | Class 1 | CX100-A1, CX100-A2, CX100-B1, CX100-BL, Tray Resin TR01 Try-in Resin TN11 A1 Try-in Resin TN11 A2 Try-in Resin TN11 A3 Try-in Resin TN11 A3.5, DT01-LT; DT01-LRP ;DT01-OP ;DT01-DK, Indirect Bonding Tray Resin IBT, Try-in Resin TN11 B1; Try-in Resin TN11 B2; Try-in Resin TN11 B3; Try-in Resin TN11 BL; DM03; DM12; OD02; W20; DT01-OR; | 2022 | 41 |
| Material, Tooth Shade, Resin | Class 2 | Dura-Crown, LumiCera, Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | 2025 | 10 |
| Positioner, Tooth, Preformed | Class 1 | Splint Soft Resin SS01; Splint Hard Resin SH01 | 2023 | 19 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | Denture Base Resin DT20 | 2025 | 14 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Shining 3D® | EBF | 76 |
| Shining 3D® | EBH | 17 |
| Shining 3D® | PZY | 14 |
| Shining 3D® | EBG | 4 |
| Shining 3D® | EBI | 3 |
| Shining 3D® | KMY | 2 |
| Shining 3D® | NDP | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261356 | 2026-04-27 | EBF | Special | This company |
| K261261 | 2026-04-17 | EBG | Traditional | This company |
| K260170 | 2026-01-21 | EBF | Traditional | This company |
| K253053 | 2025-09-23 | EBF | Traditional | This company |
| K250946 | 2025-03-31 | EBI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 1250+ |
| Main products | Intraoral scanners, Facial scanners, Dental 3D printers, Lab scanners, Design software |
| Certifications | ISO/IEC 27001, ISO 27017, ISO 27018, ISO 27701, DDS, iDD, IF Design Award 2026, Red Dot Award |
| Export markets | 100+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.