Shining 3d Tech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 3 device types, 21 products catalogued.
Shining 3D Tech Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Accessories, Implant, Dental, Endosseous, Device, Jaw Tracking, For Monitoring Jaw Positions and 1 other device type. 21 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | Shining 3D Tech Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010173003 |
| FEI number | 3010173003 |
| DUNS | 529835314 |
| Establishment type | Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 先临三维科技股份有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.1398 Xiangbin Road, Wenyan Street, Xiaoshan District |
| 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 | CS-A40-A, CS-A38M2-A, CS-A35-A, CS-A35-B, CS-B48-H,CS-B48-I,CS-B48-J,CS-B48-K,CS-B48-L, HACS-A20-4, HACS-A20-5, HACS-A25-1, HACS-A25-2, HACS-A25-3, HACS-A25-4, HACS-A25-5, Torque Wrench, Scanbody:HACS-A15-1, HACS-A15-2, HACS-A15-3, HACS-A15-4, HACS-A15-5, HACS-A20-1, HACS-A20-2, HACS-A20-3, Scanbody:CS-A48-A, CS-A48-B, CS-A48-C, CS-A48-D, CS-A48-E, CS-A48-F, CS-A48-G, CS-A48-H and 5 more | 2024 | 70 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | Class 1 | MetiSmile, MetiSmile-MR | 2023 | 1 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | System, Optical Impression, Aoralscan Elf Pro, Aoralscan 2, Aoralscan 3, Intelliscan 3X, ez2scan, Detection Eye, Dcraft-1,Dcraft-2,Dcraft-3,Dcraft-4, ACCUFAB-F1, AccuFab-CEL and 5 more | 2013 | 36 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Shining 3D® | NDP | 339 |
| Shining 3D® | NOF | 58 |
| cameo™ | NOF | 6 |
| Shining 3D® | NFS | 5 |
| Opera System® | NOF | 4 |
| Shining 3D® Intraoral Scanner | NOF | 3 |
| Intelliscan 3D® Intraoral Scanner | NOF | 3 |
| SHINING3D® | NOF | 3 |
| Zirkonzahn® | NOF | 2 |
| Marathon® | NOF | 2 |
| Adite® | NOF | 1 |
| xiujizhijia® | NOF | 1 |
| ThunPure™ | NOF | 1 |
| Dentsply Sirona® | NOF | 1 |
| Marathon® | NFS | 1 |
| Shining 3D® | EBH | 1 |
| ez2scan™ | NOF | 1 |
| Largev® | NOF | 1 |
| Shining 3D® | OFY | 1 |
| Dentium® | NOF | 1 |
| Opera System® | NFS | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 500+ R&D staff (~40% of total workforce) |
| Factory area | 64 acres (占地64亩); building area ~140,000 sqm |
| Main products | 3D scanning systems (handheld, laser, blue-light), Dental digitization products, Oral impression scanners, 3D printers for dental |
| Certifications | ISO9001, ISO14001, ISO45001, ISO13485, KGMP, MDSAP, CE, FDA, FCC, CNAS, German PTB, AEO, ISO/IEC 27001/27701/27017/27018 |
| Export markets | 100+ countries worldwide (~70% international revenue) |
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.