Manufacturer registered with FDA
SS Global
Bucheon, South Korea. Lists 1 dental device type with FDA across 0 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 0—
Registered in 3 markets
Where regulators' registries name SS Global 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 | SS Global | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SS Global | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SS GLOBAL | 2 | 2014–2021 | 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 SS Global currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Clean Cord | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096618). 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.