DD Bio ZX² color G5900020

GUDID EDDIG59000201

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: EDDIG59000201
• NIH Device Record Key: c91b99d2-c5c5-477b-b616-0dfa100da153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Bio ZX² color
• Version Model Number: 98H10 medium
• Catalog Number: G5900020
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG59000201 [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 color ]

• EDDIG59602101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59602001: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601801: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601701: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601501: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601401: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601201: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59601001: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600801: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600701: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600501: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600401: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600201: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59600101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59502101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59502001: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501801: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501701: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501501: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501401: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501201: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59501001: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500801: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500701: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500501: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500401: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500301: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500201: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59500101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59402101: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59402001: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401901: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401801: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401701: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401601: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401501: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro
• EDDIG59401401: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental pro