DD cube ONE G820

GUDID EDDIG8201

DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD cube ONE can be used for all dental constructions with up to two bridge elements in the front and side tooth area.

Dental Direkt GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: EDDIG8201
• NIH Device Record Key: 19d8f54a-2355-49b8-b7dc-8443825b0819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD cube ONE
• Version Model Number: 98H10
• Catalog Number: G820
• 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	EDDIG8201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170885

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: 2018-01-05

On-Brand Devices [DD cube ONE]

• EDDIG8261: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8251: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8241: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8221: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8201: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8271: DD cube ONE® ML are dental mill blanks made from zirconium dioxide for the manufacture of denta
• EDDIG8231: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG8211: DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental pro