Manufacturer registered with FDA
Shenzhen Yongchanghe Technology Co., Ltd.
Shenzhen, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Yongchanghe 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 | Shenzhen Yongchanghe Technology Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Yongchanghe Technology CO. ,Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHENZHEN YONGCHANGHE 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 Shenzhen Yongchanghe 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 Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Tray resin, Ortho model resin, Pro model resin, Gingiva mask resin | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dental casting resin | 2024 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Permanent Crown Resin | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | SG resin | 2022 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Denture Base Resin, Temporary C&B resin | 2024 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Ortho IBT resin | 2022 |
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 |
|---|---|---|
| SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD.FDA reg. 3022519816 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084631). 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.