DD cubeX² color G712008

GUDID EDDIG7120081

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: EDDIG7120081
• NIH Device Record Key: a499b07e-0d8e-4dd4-bdb7-d6866c95b0e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD cubeX² color
• Version Model Number: 98H14 A4
• Catalog Number: G712008
• 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
• 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
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de

Device Dimensions

• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG7120081 [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: 2016-10-05

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• EDDIG7160031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7160021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7160011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150091: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
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• EDDIG7150071: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150061: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150051: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150041: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7150011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140141: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140131: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140121: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140111: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140101: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140091: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140081: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140071: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140061: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140051: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140041: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140031: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140021: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7140011: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7120161: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par
• EDDIG7120151: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced par