Data / Medical devices / Hungary / Kerox KFT.
Kerox KFT.: FDA-registered device maker in Soskut Pest, Hungary, 1 510(k) clearance
Kerox KFT. is registered with the FDA (registration 3009740550) in Soskut Pest, Hungary. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009740550
- Address
- Kerox Utca 1, Soskut Pest, Hungary, 2038
- Owner or operator
- Kerox Kft. (10041432)
- Roles
- Manufacturer
- First device listed
- July 23, 2012
- Registered through
- 2026
- Brand names listed
- Kerox Dental Zircostar, Kerox Dental Zircostar Zirconia Blank
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2012 | K120852 | ZIRCONIA BLANKS (ZIRCOSTAR) | EIH | Substantially Equivalent | Kerox, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.