Not currently registered with FDA under this name
Lysta A/S
Farum, Denmark. Named as applicant on 2 dental 510(k) clearances between 1999 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21999–1999
- Markets registered in
- 26 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Lysta A/S 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 | Lysta A/S | 2 clearances | 1999–1999 | Below |
| South Korea | MFDS | Manufacturer | Lysta A/S | 6 | 2004–2004 | 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 Lysta A/S as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Aug 1999 | K992236 | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA | EBZ Ultraviolet Activator for Polymerization |
| 23 Apr 1999 | K991138 | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA | EBZ Ultraviolet Activator for Polymerization |
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.