LuxaGlaze® 212075

GUDID EDMG2120751

Light-curing high-gloss varnish for temporaries. High gloss shine without polishing. Content: 1 bottle @ 5 ml liquid, Accessories

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental restorative material varnish

• Primary Device ID: EDMG2120751
• NIH Device Record Key: eff94ae3-7399-4a40-b8f2-1be4daa0ab46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaGlaze®
• Version Model Number: 212075
• Catalog Number: 212075
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik 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: true
• Manufacturing Date: false
• 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: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2120750 [Primary]
HIBCC	EDMG2120751 [Package]; Contains: EDMG2120750; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013179

FDA Product Code

• EBD: Coating, Filling Material, Resin

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: 2018-07-06
• Device Publish Date: 2016-09-22

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