Not currently registered with FDA under this name
Gendex Dental Systems
Deer Field, IL, United States. Named as applicant on 2 dental 510(k) clearances between 2005 and 2006. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22005–2006
- Markets registered in
- 531 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Gendex Dental Systems as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Gendex Dental Systems | 2 clearances | 2005–2006 | Below |
| South Korea | MFDS | Manufacturer | GENDEX DENTAL SYSTEMSGendex Dental Systems s.r.l. · GENDEX DENTAL SYSTEMS S.R.L. · +2 | 14 | 1998–2008 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GENDEX DENTAL SYSTEMS | 12 | 2005–2014 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Gendex Dental Systems | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Gendex Dental Systems | 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
510(k) clearances
Clearances on which FDA names Gendex Dental Systems as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Mar 2006 | K060178 | VIX WIN PRO | MUH Digital Extraoral Source X-Ray System |
| 17 Mar 2005 | K050255 | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 | EHD Extraoral with Timer X-Ray Unit |
Some of these clearances are listed with FDA today by another company: Kashmir Surgical Works (1).
Sources
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 of the most recent filing, which can be a US agent.