Not currently registered with FDA under this name
Doxa Dental AB
Uppsala, Sweden. Named as applicant on 3 dental 510(k) clearances between 2008 and 2020. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32008–2020
- Markets registered in
- 34 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Doxa 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 | Doxa Dental AB | 3 clearances | 2008–2020 | Below |
| Canada | Health Canada | Registration holder | DOXA DENTAL AB | 3 | 2011–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Doxa Dental AB | 1 | 2020–2020 | 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 Doxa Dental AB as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Nov 2020 | K201937 | Ceramir Restore QuikCap | EMA Dental Cement |
| 28 Dec 2011 | K113040 | CERAMIR CROWN & BRIDGE | EMA Dental Cement |
| 21 Aug 2008 | K081405 | XERACEM | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (1), Directa AB (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.