Not currently registered with FDA under this name
Dental Direkt of Amerika UG (Haftungsbeschraenkt)
Spenge, Germany. Named as applicant on 2 dental 510(k) clearances between 2010 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22010–2015
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Dental Direkt of Amerika UG (Haftungsbeschraenkt) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Feb 2015 | K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | EIH Porcelain Powder |
| 24 Feb 2010 | K093748 | DD BIO Z AND DD BIO Z - TRANSPA | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Dental Direkt GmbH (1), Imagine Milling Technologies, LLC (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.