Not currently registered with FDA under this name
Nouvag AG
Kaufbeuren, Germany. Named as applicant on 4 dental 510(k) clearances between 1996 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41996–2001
- Markets registered in
- 246 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Nouvag AG 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 | Nouvag AG | 4 clearances | 1996–2001 | Below |
| European Union | EUDAMED | Registration holder | NOUVAG AG | 46 | — | 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 Nouvag AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Nov 2001 | K013185 | TCM ENDO III | EFA Dental Belt and/or Gear Driven Handpiece |
| 11 May 2000 | K000710 | MD 10, SEM, SM 12, CBM | EFB Dental Air-Powered Handpiece |
| 9 Feb 1999 | K981679 | TCM 3000 AND TCM ENDO | EFB Dental Air-Powered Handpiece |
| 16 Jan 1996 | K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 | EFB Dental Air-Powered Handpiece |
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.