Question 1

What types of dental devices does Dental Direkt GmbH manufacture?

Accepted Answer

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.

Question 2

Where is Dental Direkt GmbH based, and what does that mean for their regulatory compliance?

Accepted Answer

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.

Question 3

How are Dental Direkt GmbH’s devices classified under EU regulations?

Accepted Answer

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.

Question 4

Which regulatory registries list Dental Direkt GmbH’s devices?

Accepted Answer

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.

Question 5

Why do some of Dental Direkt GmbH’s devices appear as ‘unclassified (U)’ in EU regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
DD cubeY® HL	98H20 0M2	FDA UDI	Class II	Active
DD cube ONE color	98H25 B2	FDA UDI	Class II	Unknown
DD Bio ZX² color	98H10 A4	FDA UDI	Class II	Active
DD Bio ZX² monolith zero	light brown	FDA UDI	Class II	Unknown
DD cubeX² color	98H14 A2	FDA UDI	Class II	Unknown
DD Bio ZW iso color	98H18 1333	FDA UDI	Class II	Active
DD cubeX² ML	98H18 B2	FDA UDI	Class II	Active
DD Basic Shade	A4	FDA UDI	Class II	Active
DD base P HI	98H30 pink	FDA UDI	Class II	Active
DD Bio ZX² color	71H14 medium	FDA UDI	Class II	Active
DD cube ONE ML	98H22 C1	FDA UDI	Class II	Active
DD Bio ZX² color	98H18 A4	FDA UDI	Class II	Active
DD cubeY® HL	98H18 B1	FDA UDI	Class II	Active
DD Bio ZK	20/20	FDA UDI	Class II	Active
DD Bio ZX² color	98H14 A3	FDA UDI	Class II	Active
Nacera® Pearl Natural	98H14 B2	FDA UDI	Class II	Active
DD Basic Shade	C3	FDA UDI	Class II	Active
DD cubeY® HL	98H18 B3	FDA UDI	Class II	Active
DD Bio ZX²	98H25	FDA UDI	Class II	Active
DD Bio ZX²	98H16	FDA UDI	Class II	Active
DD cubeX² color	98H20 C1	FDA UDI	Class II	Unknown
DD Prefab MDK	DEV 36 Set	FDA UDI	Class II	Active
DD Implant Screw	DEV 30	FDA UDI	Class II	Active
DD cubeX² color	98H18 A3.5	FDA UDI	Class II	Unknown
DD Scanbody 2.0	ZTA 35 Set	FDA UDI	Class I	Active
DD cubeX²	98H20	FDA UDI	Class II	Active
DD Bio ZX²	95H12	FDA UDI	Class II	Active
DD Bio ZX² color	98H18 high chromatic	FDA UDI	Class II	Active
DD Bio ZX² monolith zero	D3+	FDA UDI	Class II	Unknown
DD Prefab	ZBC 41/50 Set	FDA UDI	Class II	Active
DD Pro Shade C	C4	FDA UDI	Class II	Active
DD Prefab MDK	SBO 41/48 Set	FDA UDI	Class II	Active
DD Prefab MDK	DEV 48 Set	FDA UDI	Class II	Active
DD cube ONE color	98H20 A3.5	FDA UDI	Class II	Unknown
DD Bio ZW iso color	98H20 500	FDA UDI	Class II	Active
DD Ti-Base 2CUT noLock	ZBC 34 Set	FDA UDI	Class II	Active
DD Prefab	SBO 33 Set	FDA UDI	Class II	Active
Nacera® Pearl Natural	98H25 B4	FDA UDI	Class II	Active
DD Bio ZX²	65/25	FDA UDI	Class II	Active
DD Bio ZX² color	98H14 B3	FDA UDI	Class II	Active
DD Bio ZX² color	98H20 B1	FDA UDI	Class II	Active
DD Bio ZX²	55/19	FDA UDI	Class II	Active
DD Bio ZW iso color	98H20 C1	FDA UDI	Class II	Active
DD cubeX² color	98H25 B3	FDA UDI	Class II	Unknown
DD Basic Shade	A2	FDA UDI	Class II	Active
DD cube ONE ML	98H18 D2	FDA UDI	Class II	Active
DD base P HI	98H25 sun	FDA UDI	Class II	Active
DD Prefab	SSY 65 Set	FDA UDI	Class II	Active
DD Bio ZW iso color	98H18 2000	FDA UDI	Class II	Active
DD contrast color	fissure	FDA UDI	Class II	Active

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