Not currently registered with FDA under this name
Harald Nordin S.A
Montreux, Switzerland, Switzerland. Named as applicant on 3 dental 510(k) clearances between 1994 and 2000. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31994–2000
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Harald Nordin S.A 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 | Harald Nordin S.A | 3 clearances | 1994–2000 | Below |
| South Korea | MFDS | Manufacturer | HARALD NORDIN S.A | 1 | 2021–2021 | 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
510(k) clearances
Clearances on which FDA names Harald Nordin S.A as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Oct 2000 | K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | ELR Root Canal Post |
| 25 Oct 2000 | K003219 | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | ELR Root Canal Post |
| 28 Apr 1994 | K931396 | DENTAL SCREW POSTS | ELR Root Canal Post |
Some of these clearances are listed with FDA today by another company: Parkell, Inc (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.