Manufacturer registered with FDA
Dacheng Huaguan Dental Instruments Co., Ltd.
Langfang, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 513 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Dacheng Huaguan Dental Instruments 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 | Dacheng Huaguan Dental Instruments Co., Ltd. | 4 device types | — | Below |
| Australia | TGA | Manufacturer | Dacheng Huaguan Dental Instruments Co Ltd | 4 | 2015–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dacheng Huaguan Dental Instruments Co., Ltd.Dacheng Huaguan Dental Instruments Co., Ltd | 4 | 2013–2022 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DACHENG HUAGUAN DENTAL INSTRUMENTS CO., LTD.DACHENG HUAGUAN DENTAL INSTRUMENTS CO., Ltd. | 3 | 2022–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dacheng Huaguan Dental Instruments Co., Ltd | 2 | 2025–2026 | 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 Dacheng Huaguan Dental Instruments 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 | MouthpiecePlastic TubesSaliva Ejector | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Bite Trayimpression tray | 2013 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | EvacuatorOral CavitySurgical Aspirator Tip | 2013 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Plastic HolderPlastic Traps | 2014 |
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 |
|---|---|---|
| Dacheng Huaguan Dental Instruments Co., LtdFDA reg. 3011169597 | Langfang Hebei, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045372). 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.