DD cubeX² ML G856009

GUDID EDDIG8560091

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.

Dental Direkt GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: EDDIG8560091
• NIH Device Record Key: 7f7cddfa-eb79-4e23-9aea-07322f3ab9bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD cubeX² ML
• Version Model Number: 98H22 A4
• Catalog Number: G856009
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de

Device Dimensions

• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 22 Millimeter
• Outer Diameter: 98.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG8560091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150196

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-08
• Device Publish Date: 2022-12-09

On-Brand Devices [DD cubeX² ML]

• EDDIG8560081: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560071: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560061: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560051: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560041: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540081: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540071: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540061: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540051: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540041: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520081: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520071: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520061: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520051: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520041: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560171: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540171: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520171: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8560091: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8540091: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG8520101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par