Not currently registered with FDA under this name
Nordiska Dental AB
Lynwood, WA, United States. Named as applicant on 4 dental 510(k) clearances between 1999 and 2000. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41999–2000
- Markets registered in
- 25 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Nordiska Dental AB 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 | Nordiska Dental AB | 4 clearances | 1999–2000 | Below |
| South Korea | MFDS | Manufacturer | Nordiska Dental AB | 5 | 2000–2011 | 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 Nordiska Dental AB as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Oct 2000 | K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | EJJ Amalgam Alloy |
| 31 Oct 2000 | K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | EJJ Amalgam Alloy |
| 31 Oct 2000 | K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | EJJ Amalgam Alloy |
| 22 Sep 1999 | K992161 | CERANA | EIH Porcelain Powder |
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.