Manufacturer registered with FDA
Kerox Kft.
Soskut, Hungary. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12012–2012
- Markets registered in
- 511 registrations outside the US
- Establishments
- 1Hungary
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Kerox Kft. 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 | Kerox Kft. | 1 clearances | 2012–2012 | Below |
| Saudi Arabia | SFDA | Manufacturer | Kerox Ltd | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KEROX LTD | 1 | 2017–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | KEROX Kft | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kerox Kft. | 1 | 2015–2015 | 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 Kerox Kft. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Kerox Dental ZircostarKerox Dental Zircostar Zirconia Blank | 2012 |
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 |
|---|---|---|
| KEROX KFT.FDA reg. 3009740550 | Soskut Pest, Hungary | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041432). 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.