Nacera 4000LQ7116

GUDID EDMC4000LQ71160

Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium oxide, especially for Nacera® Pearl 1. 16 + 2 shades, 4 effect liquids, balancer, diluting.

DOCERAM medical ceramics GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: EDMC4000LQ71160
• NIH Device Record Key: b64cb82f-7d74-445d-92ac-7d96fd77ec0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nacera
• Version Model Number: Classic Liquid Set
• Catalog Number: 4000LQ7116
• Company DUNS: 537713567
• Company Name: DOCERAM medical ceramics 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: false
• 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: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMC4000LQ71160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092020

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: 8
• Public Version Date: 2020-02-10
• Device Publish Date: 2016-12-22

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