Manufacturer registered with FDA
Jinyuan medical equipment(tianjin)co.,ltd
Tianjin, China. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Jinyuan medical equipment(tianjin)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 | Jinyuan medical equipment(tianjin)co.,ltd | 16 device types | — | Below |
| Australia | TGA | Manufacturer | Jinyuan Medical Equipment (Tianjin) Co Ltd | 1 | 2022–2022 | 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 Jinyuan medical equipment(tianjin)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 | 2019 |
| Roll CottonEFN · Class 1 | — | Maker | N/A | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | N/A | 2024 |
| X-Ray Beam AlignerEHA · Class 1 | — | Maker | N/A | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Disposable Impression Tray/ Bite Registration Tray/ Fluoride Impression Tray/ Bite Whitening Tray | 2019 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | N/A | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | N/A | 2024 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | N/A | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | N/A | 2024 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | N/A | 2024 |
| Tube Impression and MatrixKCQ · Class 1 | — | Maker | N/A | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Patient Paper/Poly towel | 2019 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Disposable Impression Tray/ Bite Registration Tray/ Fluoride Impression Tray/ Bite Whitening Tray | 2023 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier Film/ Keyboard Film | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | N/A | 2024 |
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 |
|---|---|---|
| JINYUAN MEDICAL EQUIPMENT(TIANJIN)CO.,LTDFDA reg. 3015276580 | Tianjin, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062125). 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.