DD Bio ZW iso color G5225000

GUDID EDDIG52250001

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: EDDIG52250001
• NIH Device Record Key: 54acece9-b53d-402a-9c7f-2209265728bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Bio ZW iso color
• Version Model Number: 98H14 500
• Catalog Number: G5225000
• 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 Dimensions

• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDIG52250001 [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 ZW iso color]

• EDDIG520A101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526D201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526C101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526B201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526B101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526A3501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526A301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526A201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526A101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525D201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525C101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525B201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525B101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525A3501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525A301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525A201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525A101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524D201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524C101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524B201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524B101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524A3501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524A301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524A201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG524A101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522D201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522C101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522B201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522B101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522A3501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522A301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522A201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG522A101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520D201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520C101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520B201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520B101: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520A3501: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520A301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG520A201: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG596100001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG52680001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG52650001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526200001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG526133301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG52580001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG52550001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525200001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525133301: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth
• EDDIG525100001: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prosth