Manufacturer registered with FDA
Shenzhen Hengdasheng Technology Co., Ltd
Shenzhen, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Hengdasheng 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 | Shenzhen Hengdasheng Technology Co., Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Hengdasheng Technology Co., Ltd | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shenzhen Hengdasheng Technology 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 Shenzhen Hengdasheng 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 |
|---|---|---|---|---|
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | gauze / sponge,nonresorbable for external use - Gauze Sponges | 2025 |
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 |
|---|---|---|
| SHENZHEN HENGDASHENG TECHNOLOGY CO., LTDFDA reg. 3040389256 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093867). 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.