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DD cubeX² color

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD cubeX² color 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
98H25 B4 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
G716011 FDA UDI
Primary DI / UDI-DI
EDDIG7160111 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 98.5 Millimeter FDA UDI
Height — 25 Millimeter FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Direkt GmbH

Sources (1)

  • FDA UDI 740d91ce-9037-4b6b-9e24-30518a2a005b 37 fields · synced May 31, 2026