DD cubeX² G710

GUDID EDDIG7101

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: EDDIG7101
• NIH Device Record Key: 77815f95-e5b3-4e9e-8f60-01df5b60215a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD cubeX²
• Version Model Number: 98H10
• Catalog Number: G710
• 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
• Phone: +495225863190
• Email: info@dentaldirekt.de

Device Dimensions

• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 98.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG7101 [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: 3
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-23

On-Brand Devices [DD cubeX²]

• EDDIG7761: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7751: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7741: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7721: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7701: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par