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Sign in to claim this brandDental Direkt GmbH
Germany·DE-MF-000006592
Last updated September 17, 2026
What Dental Direkt GmbH makes
Dental Direkt GmbH produces dental appliance fabrication materials, including ceramic and thermoplastic variants, as well as preformed permanent dental implant suprastructures. Their portfolio also includes temporary crowns and bridges, intraoral-scanning abutment analogs for single-use, and dental prosthesis dyes for customisation. The company supplies materials and components used in dental prosthetics and restorative procedures, such as base materials for denture fabrication and pre-shaded ceramic blocks for milling.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, with some listed as unclassified (U). Their products are registered in the EU’s eudamed database and the FDA’s UDI system. Dental Direkt GmbH is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Dental Direkt GmbH manufacture?
Dental Direkt GmbH specialises in materials and components for dental prosthetics and restorative treatments. Their portfolio includes ceramic and thermoplastic dental appliance fabrication materials, preformed permanent dental implant suprastructures, temporary crowns and bridges, intraoral-scanning abutment analogs (single-use), and dyes for customising dental prostheses. These products support key stages of dental restoration, from fabrication to final fitting.
Where is Dental Direkt GmbH based, and what does that mean for their regulatory compliance?
Dental Direkt GmbH is based in Germany, which means their devices are subject to EU Medical Device Regulations (MDR). The company’s products are registered in the EU’s official database, eudamed, ensuring transparency and traceability under EU law. Their devices are also listed in the FDA’s UDI system, reflecting compliance with U.S. requirements, though this does not imply approval—only that their devices are authorised for distribution in those markets.
How are Dental Direkt GmbH’s devices classified under EU regulations?
Dental Direkt GmbH’s devices fall into multiple EU risk classes depending on their intended use and potential risk to patients. Most of their products are classified as Class I (low risk, e.g., some fabrication materials) or Class IIa/IIb (moderate risk, e.g., implant suprastructures or temporary crowns). A few are listed as unclassified (U), meaning they may not require CE marking but still adhere to EU safety standards. Classification determines regulatory pathways, such as clinical evaluation requirements or post-market surveillance obligations.
Which regulatory registries list Dental Direkt GmbH’s devices?
Dental Direkt GmbH’s devices are officially listed in two key global registries: eudamed, the EU’s centralised database for medical devices, and the FDA’s UDI (Unique Device Identification) system, which tracks devices in the U.S. market. These registries ensure traceability and compliance with respective jurisdictions’ medical device laws, though listing alone does not confirm device approval—only that they meet regulatory submission requirements.
Why do some of Dental Direkt GmbH’s devices appear as ‘unclassified (U)’ in EU regulations?
The ‘unclassified (U)’ designation under EU MDR applies to devices that do not fit neatly into the standard risk classes (I, IIa, IIb, or III) due to their minimal risk profile or non-invasive nature. For example, certain fabrication materials or dyes may not require CE marking because they pose negligible risk to patients when used as intended. However, even unclassified devices must still comply with EU safety, performance, and traceability requirements, including registration in eudamed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 106-108, Industriezentrum , Spenge, Germany
- Website
- www.dentaldirekt.de
- —
- —
- [email protected]
- Phone
- +495225863190
- PRRC Contact
- Nils Olberts
- EUDAMED SRN
- DE-MF-000006592
- FDA FEI Number
- 3008347275
- DUNS Number
- 313214171
Catalogue (1254)
Page 2 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DD Bio ZX² color | 98H18 A2 | FDA UDI | Class II | Active |
| DD Basic Shade | C4 | FDA UDI | Class II | Active |
| DD Bio ZX² | 95H14 | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H25 medium | FDA UDI | Class II | Active |
| DD Bio ZW iso color | 98H14 B2 | FDA UDI | Class II | Active |
| DD cube ONE ML | 98H18 D4 | FDA UDI | Class II | Active |
| DD Prefab | NNA 43/50 Set | FDA UDI | Class II | Active |
| DD cube ONE color | 98H18 C2 | FDA UDI | Class II | Unknown |
| DD cube ONE color | 98H25 B3 | FDA UDI | Class II | Unknown |
| DD Bio ZX² monolith zero | A3 | FDA UDI | Class II | Unknown |
| DD cubeX² color | 98H18 A2 | FDA UDI | Class II | Unknown |
| DD cubeX² color | 98H10 C3 | FDA UDI | Class II | Unknown |
| Nacera Pearl Shaded 16+2 | 98.3x38 A1 | FDA UDI | Class II | Active |
| DD Bio Splint P HI | 98H20 | FDA UDI | U | Active |
| DD Bio ZX² color | 98H10 high chromatic | FDA UDI | Class II | Active |
| DD Bio ZX² | 95H18 | FDA UDI | Class II | Active |
| DD Prefab | CCA 50 Set | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H20 D3 | FDA UDI | Class II | Active |
| DD cube ONE ML | 98H22 A3.5 | FDA UDI | Class II | Active |
| DD cubeY® HL | 98H25 C3 | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H10 C1 | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H25 low chromatic | FDA UDI | Class II | Active |
| DD Bio ZW iso color | 98H20 B2 | FDA UDI | Class II | Active |
| DD cubeY® HL | 98H25 B4 | FDA UDI | Class II | Active |
| DD Bio ZW iso | 98H20 | FDA UDI | Class II | Active |
| DD Bio ZW iso color | 98H18 C1 | FDA UDI | Class II | Active |
| DD Scanbody 2.0 | ZBC 34 Set | FDA UDI | Class I | Active |
| DD Bio ZX² color | 98H10 D4 | FDA UDI | Class II | Active |
| DD tempMED | 98H15 A2 | FDA UDI | Class II | Active |
| DD Basic Shade | A2 | FDA UDI | Class II | Active |
| DD Bio ZX² monolith zero | A4 | FDA UDI | Class II | Unknown |
| DD cubeY® HL | 98H20 B2 | FDA UDI | Class II | Active |
| DD cube ONE color | 98H25 C2 | FDA UDI | Class II | Unknown |
| Nacera Pearl Shaded 16+2 | 98.3x18 0M2 | FDA UDI | Class II | Active |
| Nacera® Pearl Natural | 98H20 C2 | FDA UDI | Class II | Active |
| DD Bio ZX² monolith zero | SA2 | FDA UDI | Class II | Unknown |
| DD contrast color | traces | FDA UDI | Class II | Active |
| Nacera Pearl Shaded 16+2 | 98.3x25 C1 | FDA UDI | Class II | Active |
| DD Prefab | ZTA 35 Set | FDA UDI | Class II | Active |
| DD Bio ZX² monolith zero | OM3 | FDA UDI | Class II | Unknown |
| DD cubeX² ML | 98H22 A3 | FDA UDI | Class II | Active |
| Nacera Pearl Shaded 16+2 | 98.3x38 A3 | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H18 A3 | FDA UDI | Class II | Active |
| DD Bio ZW iso color | 98H18 A1 | FDA UDI | Class II | Active |
| Nacera® Pearl Natural | 98H30 D2 | FDA UDI | Class II | Active |
| DD Pro Shade C | Set | FDA UDI | Class II | Active |
| DD Ti-Base 2CUT noLock | SBO 33 Set | FDA UDI | Class II | Active |
| DD Bio ZX² color | 98H10 A1 | FDA UDI | Class II | Active |
| DD Pro Shade Z | B4 | FDA UDI | Class II | Active |
| DD Bio ZW iso color | 98H14 B1 | FDA UDI | Class II | Active |
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