Manufacturer registered with FDA
Guangzhou Four E's Scientific Co., Ltd.
Guangzhou, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Guangzhou Four E's Scientific 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 | Guangzhou Four E's Scientific Co., Ltd. | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | Guangzhou Four E's Scientific Co., Ltd | 3 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Guangzhou Four E’s Scientific 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 Guangzhou Four E's Scientific 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Irrigation Tubes | 2020 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Aiming RingFilm HolderIndicator ArmRadiography HolderSensor HolderX-Ray Film Holder | 2024 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Cup | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Dental Metal Brackets | 2024 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Dental Articulator | 2026 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | Matrix BandsMatrix RetainersSectional Matrix System | 2024 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Electric Toothbrush | 2021 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | Dental Mixing Tips | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Torque RatchetTorque Wrench | 2023 |
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 |
|---|---|---|
| Guangzhou Four E's Scientific Co., Ltd.FDA reg. 3009155756 | GUANGZHOU Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035903). 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.