DD Bio ZX² monolith zero LV002

GUDID EDDILV0021

DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations.

Dental Direkt GmbH

Dental prosthesis dye

• Primary Device ID: EDDILV0021
• NIH Device Record Key: 287c8c2a-6e43-4aa5-991d-8d78fc9961df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Bio ZX² monolith zero
• Version Model Number: Vario
• Catalog Number: LV002
• 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

Device Dimensions

• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter
• Total Volume: 30 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDILV0021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150196

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-05

On-Brand Devices [DD Bio ZX² monolith zero]

• EDDILZS0051: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZS0041: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZS0031: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZS0021: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZS0011: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0621: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0611: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0601: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0591: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0571: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0551: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0531: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0511: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0121: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0111: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0101: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0091: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0071: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0051: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0031: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZP0011: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0061: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0051: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0041: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0031: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0021: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZE0011: dark pink
• EDDILZD0661: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0651: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0641: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0631: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0621: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0611: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0601: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0591: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0581: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0571: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0561: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0551: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0541: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0531: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0521: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0511: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0161: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0151: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0141: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0131: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0121: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0111: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco
• EDDILZD0101: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirco