Manufacturer registered with FDA
Shining 3D Tech Co., Ltd.
Hangzhou, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12110 registrations outside the US
- Establishments
- 1China
Registered in 12 markets
Where regulators' registries name Shining 3D Tech Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shining 3D Tech Co., Ltd. | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | SHINING 3D TECH CO., LTD. | 23 | 2021–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shining 3D Tech Co., Ltd.Shining 3D Tech Co.,Ltd · Shining 3D Tech.co.ltd | 14 | 2016–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shining 3D Tech Co., Ltd. | 13 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shining 3D Tech Co Ltd | 9 | 2021–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Shining 3D Tech Co., Ltd.SHINING 3D Tech Co., Ltd. · Shining 3D Tech Co.,Ltd. · +1 | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHINING 3D TECH CO., LTD.SHINING 3D TECH. · Shining 3D Tech Co., Ltd. | 9 | 2017–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Shining 3D Tech Co., Ltd. | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHINING 3D TECH CO., LTD. | 7 | 2022–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shining 3D Tech Co., Ltd. | 7 | 2022–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHINING 3D TECH CO., LTD. | 6 | 2023–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shining 3D Tech Co., Ltd. | 5 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shining 3D Tech Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | CS-A40-A, CS-A38M2-A, CS-A35-A, CS-A35-BCS-A40-B, CS-A60M2-A, CS-A40-C, CS-A41M2-A, CS-A58-ACS-A48-I, CS-A48-J, CS-A48-K, CS-A48-L, CS-A48M2-A, CS-A43-A, CS-A43-BCS-B48-H,CS-B48-I,CS-B48-J,CS-B48-K,CS-B48-LHACS-A20-4, HACS-A20-5, HACS-A25-1, HACS-A25-2, HACS-A25-3, HACS-A25-4, HACS-A25-5Scanbody:CS-A48-A, CS-A48-B, CS-A48-C, CS-A48-D, CS-A48-E, CS-A48-F, CS-A48-G, CS-A48-HScanbody:CS-B48-A,CS-B48-B,CS-B48-C,CS-B48-D,CS-B48-E,CS-B48-F,CS-B48-GScanbody:HACS-A15-1, HACS-A15-2, HACS-A15-3, HACS-A15-4, HACS-A15-5, HACS-A20-1, HACS-A20-2, HACS-A20-3Scanbody:HACS-IPG, HAFS-IFTSCS Screwdriver for Ratchet 1 moreTorque Wrench | 2024 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Maker | MetiSmile, MetiSmile-MR | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | AccuFab-CELACCUFAB-F1Aoralscan 2, Aoralscan 3, Intelliscan 3X, ez2scan, Detection EyeAoralscan Elf ProAutoScan-DS-EX Pro(C), A-IS Pro, OS-200, Capella M2AutoScan-DS-EX Pro(H), A-IS Pro3, OS GOLDY, Capella M5Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations with Ceramix-NanoDcraft-1,Dcraft-2,Dcraft-3,Dcraft-4SN3D-AI, Dental CopilotSystem, Optical Impression 1 moreVNX-S100 | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Shining 3D Tech Co.,Ltd.FDA reg. 3010173003 | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045483). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.