DD Bio ZX² G5942

GUDID EDDIG59421

DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio ZX² 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: EDDIG59421
• NIH Device Record Key: c965fd7a-3ea9-47ef-8b89-d9706803d935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Bio ZX²
• Version Model Number: 98H18
• Catalog Number: G5942
• 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

• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG59421 [Primary]

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: 2016-10-05

On-Brand Devices [DD Bio ZX² ]

• EDDIG61331: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG6131: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG61301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG61211: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG6111: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG61011: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG6101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59621: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5961: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59521: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5951: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59421: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5941: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5931: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59221: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5921: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5911: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG5901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3671: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3661: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3651: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3641: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3631: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3621: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3611: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG3601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2661: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2651: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2641: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2631: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2621: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2611: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2351: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2341: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2331: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2321: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2311: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG2301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro