DD Bio ZS G604.1

GUDID EDDIG60411

DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio Z 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: EDDIG60411
• NIH Device Record Key: 012812e0-5b00-4c95-be5d-2dc1f6789fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Bio ZS
• Version Model Number: 55/19
• Catalog Number: G604.1
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• Device Count: 2
• 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

Device Dimensions

• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter
• Height: 15.5 Millimeter
• Width: 19 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG60411 [Primary]
HIBCC	EDDIG604111 [Unit of Use]
HIBCC	EDDIG6041X [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142987

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: 2016-11-30

On-Brand Devices [DD Bio ZS ]

• EDDIG6071: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG60531: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG6051: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG60501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG60411: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG6041: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG60311: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG6031: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG6021: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG6011: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG60011: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG6001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth