Manufacturer registered with FDA
Yongqing Huaguan Dental Instruments Factory
Langfang City, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Yongqing Huaguan Dental Instruments Factory 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 | Yongqing Huaguan Dental Instruments Factory | 8 device types | — | Below |
| Australia | TGA | Manufacturer | Yongqing Huaguan Dental Instruments Factory | 1 | 2020–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Yongqing Huaguan Dental Instruments Factory | 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 Yongqing Huaguan Dental Instruments Factory 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 | Mouthpiece, Saliva Ejector | 2021 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/Water Syringe Tips | 2018 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | dental mixing well | 2022 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Tray, impression ,Preformed | 2021 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator, Oral Cavity | 2021 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Patient BibsPoly BibsPoly Towels | 2019 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier FilmsPlastic BagsPlastic Covers | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Barrier Films, Plastic Covers, Plastic Bags | 2018 |
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 |
|---|---|---|
| Yongqing Huaguan Dental Instruments FactoryFDA reg. 3014345250 | Langfang City Hebei, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057201). 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.