Manufacturer registered with FDA
Xiamen Zhiyuan Medical Technology Co.,Ltd
Xiamen, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Xiamen Zhiyuan Medical 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 | Xiamen Zhiyuan Medical Technology Co.,Ltd | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Xiamen Zhiyuan Medical Technology Co.,Ltd | 1 | — | 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 Xiamen Zhiyuan Medical 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 | Impression Tray | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | RESIN, MATERIAL, Impression Tray | 2023 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Surgical Aspirator Tips, AirWater Syringe Tip | 2023 |
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 |
|---|---|---|
| Xiamen Zhiyuan Medical Technology Co., Ltd.FDA reg. 3027605742 | XIAMEN Fujian, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088289). 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.