Manufacturer registered with FDA
Hangzhou SHINING3D Dental Technology Co., Ltd
Hangzhou, China. Lists 7 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 24
- 510(k) clearances
- 62025–2026
- Markets registered in
- 1147 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Hangzhou SHINING3D Dental Technology 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 | Hangzhou SHINING3D Dental Technology Co., Ltd | 6 clearances | 2025–2026 | Below |
| Australia | TGA | Manufacturer | Hangzhou SHINING3D Dental Technology Co Ltd | 10 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hangzhou SHINING3D Dental Technology Co., Ltd. | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD. | 6 | 2026–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Hangzhou SHINING3D Dental Technology Co., Ltd. | 5 | 2023–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD. | 4 | 2025–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｈａｎｇｚｈｏｕ ＳＨＩＮＩＮＧ３Ｄ Ｄｅｎｔａｌ Ｔｅｃｈｎｏｌｏｇｙ Ｃｏ．， Ｌｔｄ．Ｈａｎｇｚｈｏｕ ＳＨＩＮＩＮＧ３Ｄ Ｄｅｎｔａｌ Ｔｅｃｈｎｏｌｏｇｙ Ｃｏ．，Ｌｔｄ． | 4 | 2025–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Hangzhou SHINING3D Dental Technology Co., Ltd. | 4 | 2025–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Hangzhou SHINING3D Dental Technology Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hangzhou SHINING 3D Dental Technology Co., Ltd. | 1 | 2026–2026 | 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 Hangzhou SHINING3D Dental Technology 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 |
|---|---|---|---|---|
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | CB11-A1CB11-A2CB11-A3CB11-A3.5CB11-B1CB11-B2CB11-B3Dura-ArchDura-CrownDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | 2023 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Dura-CrownDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)LumiCera | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Dura-ArchDura-CrownDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | 2025 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | CX100-A1, CX100-A2, CX100-B1, CX100-BLDT01-LT; DT01-LRP ;DT01-OP ;DT01-DKIndirect Bonding Tray Resin IBTTray Resin TR01 Try-in Resin TN11 A1 Try-in Resin TN11 A2 Try-in Resin TN11 A3 Try-in Resin TN11 A3.5Try-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 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Denture Base Resin DT20 | 2025 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Splint Soft Resin SS01; Splint Hard Resin SH01 | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide Resin SG01; Surgical Guide Resin SG PRO; Surgical Guide Resin SG02 | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hangzhou SHINING3D Dental Technology Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Oct 2026 | K263860 | Shining3D Clear Aligner System | NXC Sequential Aligner |
| 27 Apr 2026 | K261356 | Dura-Crown | EBF Resin Tooth Shade Material |
| 17 Apr 2026 | K261261 | Dura-Arch | EBG Resin Temporary Crown and Bridge |
| 21 Jan 2026 | K260170 | LumiCera | EBF Resin Tooth Shade Material |
| 23 Sep 2025 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | EBF Resin Tooth Shade Material |
| 31 Mar 2025 | K250946 | Denture Base Resin DT20 | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: AD Systems And Consulting (Pty) Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTDFDA reg. 3026312357 | Hangzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086991). 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.