Manufacturer registered with FDA
Dental Direkt GmbH
Spenge, Germany. Lists 6 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 23
- 510(k) clearances
- 92015–2024
- Markets registered in
- 13135 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Dental Direkt 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 | Manufacturer | Dental Direkt GmbH | 9 clearances | 2015–2024 | Below |
| Canada | Health Canada | Registration holder | DENTAL DIREKT GMBH | 61 | 2010–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Dental Direkt GmbH | 18 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dental Direkt GmbH | 14 | 2023–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dental Direkt GmbHDental Direkt GMBH | 8 | 2016–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Dental Direkt GmbH | 7 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dental Direkt GmbH | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dental Direkt GmbH | 5 | 2017–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dental Direkt GmbH | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 丹特迪瑞有限公司Dental Direkt GmbH | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTAL DIREKT GMBH | 3 | 2016–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dental Direkt GmbH | 2 | 2017–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dental Direkt GmbH | 1 | — | 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
Devices listed with FDA
What Dental Direkt GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | DD Art ElementsDD Basic ShadeDD Bio ZW isoDD Bio ZX²DD Bio ZX² colorDD contrastDD cube ONEDD cube ONE MLDD cubeX²DD cubeX² ML 5 moreDD cubeY HLDD Pro Shade CDD Pro Shade ZNacera Pearl NaturalNacera Pearl Shaded 16+2 | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DD PrefabDD Ti-Base 2CUTDD Ti-Base 2CUT noLock | 2023 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | DD poly Y ML | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DD base P HIDD Bio Splint P HI | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DD Scanbody 2 | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | i700 | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dental Direkt GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Sep 2024 | K241579 | DD Hybridlayer (multicolored zirconia) | EIH Porcelain Powder |
| 23 Jun 2023 | K230410 | DD medical polymers (PMMA) | EBI Rebasing Repairing Relining Denture Resin |
| 25 Apr 2023 | K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | NHA Endosseous Dental Implant Abutment |
| 11 Jan 2023 | K191111 | DD Solid Connect® CAD/CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 16 Apr 2020 | K193588 | DD Contrast | EIH Porcelain Powder |
| 14 Feb 2019 | K183569 | DD cube ONE ML | EIH Porcelain Powder |
| 1 Aug 2017 | K170885 | DD cubeX2 HS | EIH Porcelain Powder |
| 13 May 2016 | K153490 | DD medical polymers | EBG Resin Temporary Crown and Bridge |
| 26 Mar 2015 | K150196 | DD cubeX2 | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Proto3000 Inc. (3), Voco GmbH (1), Imagine Milling Technologies, LLC (1).
Also lists devices cleared under other names
Dental Direkt GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Doceram Medical Ceramics GmbH (1), Dental Direkt of Amerika UG (Haftungsbeschraenkt) (1), Polident d.o.o. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jun 2015 | K143071 | Nacera Pearl | Doceram Medical Ceramics GmbH | EIH Porcelain Powder |
| 11 Feb 2015 | K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | EIH Porcelain Powder |
| 28 Aug 2012 | K112967 | PMMA CAD/CAM DISC | Polident d.o.o. | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dental Direkt GmbHFDA reg. 3008347275 | Spenge North Rhine-Westphalia, Germany | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032224). 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.