Manufacturer registered with FDA
Guangdong Zhilianxing Precision Technology Co.,Ltd.
Shantou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Guangdong Zhilianxing Precision 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 | Guangdong Zhilianxing Precision Technology Co.,Ltd. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Guangdong Zhilianxing Precision Technology Co.,Ltd | 3 | — | 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 Guangdong Zhilianxing Precision 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 |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Coping | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Implant Scan BodyLab Analog | 2025 |
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 |
|---|---|---|
| GUANGDONG ZHILIANXING PRECISION TECHNOLOGY CO.,LTD.FDA reg. 3043105508 | Shantou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094551). 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.