DD Basic Shade LBS001

GUDID EDDILBS0011

DD Basic Shade are universally applicable liquids for coloring 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: EDDILBS0011
• NIH Device Record Key: f2675a0a-ebc8-4bdd-8952-a33b7f23e353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DD Basic Shade
• Version Model Number: Set
• Catalog Number: LBS001
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• Device Count: 21
• 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	EDDILBS0011 [Primary]
HIBCC	EDDILBS0019 [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: 2017-01-12

On-Brand Devices [DD Basic Shade]

• EDDILBS30D41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30D31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30D21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30C41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30C31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30C21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30C11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30B41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30B31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30B21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30B11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30A41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30A351: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30A31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30A21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS30A11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS300M31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS300M21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS300M11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100D41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100D31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100D21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100C41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100C31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100C21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100C11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100B41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100B31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100B21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100B11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100A41: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100A351: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100A31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100A21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS100A11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS1000M31: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS1000M21: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS1000M11: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const
• EDDILBS0011: DD Basic Shade are universally applicable liquids for coloring pre-sintered white zirconia const