DD Art Elements LAE001

GUDID EDDILAE0011

DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered white zirconia constructions made from DD Bio Z, DD Bio ZX² or DD cubeX² zirconia milling blanks for the manufacture of dental restorations.

Dental Direkt GmbH

Dental prosthesis dye

• Primary Device ID: EDDILAE0011
• NIH Device Record Key: cb805586-b11e-4cf5-97a5-e8e553921465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Art Elements
• Version Model Number: Set
• Catalog Number: LAE001
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• Device Count: 16
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDILAE0011 [Primary]
HIBCC	EDDILAE0019 [Unit of Use]

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: 2018-01-04

On-Brand Devices [DD Art Elements ]

• EDDILAE30Y1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30V1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30P1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30LP1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30LG1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30LB1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30G1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30DP1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30DG1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30DB1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE30B1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SOB1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SO1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SC21: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SC11: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SA21: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE15SA11: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE100V1: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered
• EDDILAE0011: DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered