Manufacturer registered with FDA
Dongguan Ouwen Medical Device Technology Co., Ltd.
Dongguan, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 516 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Dongguan Ouwen Medical Device 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 | Dongguan Ouwen Medical Device Technology Co., Ltd. | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Dongguan Ouwen Medical Device Technology Co.,Ltd | 12 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DONGGUAN OUWEN MEDICAL DEVICE TECHNOLOGY CO., LTD | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dongguan Ouwen Medical Device Technology Co Ltd | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dongguan Ouwen Medical Device Technology Co.,Ltd | 1 | 2026–2026 | 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 Dongguan Ouwen Medical Device 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | SALIVA EJECTOR | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Composite ExtruderDental Conveyor | 2021 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Disposable Air-Water Syringe Tips | 2021 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy Cup; Prophy Brush | 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 |
|---|---|---|
| DONGGUAN OUWEN MEDICAL DEVICE TECHNOLOGY CO., LTD.FDA reg. 3021386681 | Dongguan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083767). 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.