DD cubeX² ML

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name: DD cubeX² ML FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced partial or single crowns, bridges with up to 3 units (anterior and posterior region), inlays / onlays and veneers for dental application. FDA UDI
Model / Reference: 98H22 A4 FDA UDI
Description: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced partial or single crowns, bridges with up to 3 units (anterior and posterior region), inlays / onlays and veneers for dental application. FDA UDI

Identifiers

Catalog Number: G856009 FDA UDI
Primary DI / UDI-DI: EDDIG8560091 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 22 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Dental appliance fabrication material, ceramic

DD cubeX² ML by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dental Direkt GmbH

Sources (1)

FDA UDI 7f7cddfa-eb79-4e23-9aea-07322f3ab9bf 36 fields · synced May 31, 2026