DD cubeX² G770

GUDID EDDIG7701

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: EDDIG7701
• NIH Device Record Key: 3bd559a0-71d2-4bb1-bb3c-fc9ff53475c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD cubeX²
• Version Model Number: 95H10
• Catalog Number: G770
• 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: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 10 Millimeter
• Outer Diameter: 95 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG7701 [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: 2017-01-12

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