Not currently registered with FDA under this name
Tomed Dr. Toussaint GmbH
Bensheim, Germany. Named as applicant on 2 dental 510(k) clearances between 2006 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22006–2012
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Tomed Dr. Toussaint GmbH 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 | Tomed Dr. Toussaint GmbH | 2 clearances | 2006–2012 | Below |
| Taiwan | TFDA | Manufacturer | TOMED DR. TOUSSAINT GMBH | 1 | 2009–2009 | 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 Tomed Dr. Toussaint GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Sep 2012 | K121761 | SOMNOGUARD SP SOFT | LRK Anti-Snoring Device |
| 8 Sep 2006 | K061688 | ANTI-SNORING / SLEEP APNEA DEVICE | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Tomed GmbH (2).
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.