Manufacturer registered with FDA
TianJin Jieyaxin Medical Plastic Equipment Co., Ltd.
Tianjin, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name TianJin Jieyaxin Medical Plastic Equipment 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 | TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | 5 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tianjin Jieyaxin Medical Plastic Equipment 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 TianJin Jieyaxin Medical Plastic Equipment 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | saliva ejector | 2019 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/water syringe tip | 2022 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | impression tray | 2019 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points, Gutta Percha Obturator | 2021 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2021 |
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 |
|---|---|---|
| TIANJIN JIEYAXIN MEDICAL PLASTIC EQUIPMENT CO., LTD.FDA reg. 3015461866 | Tianjin, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060501). 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.