LuxaCrown 120976

GUDID EDMG1209761

Self-curing Composite for the fabrication of semipermanent crowns and bridges. The material is mixed automatically. Content: 1 cartridge @ 50 ml paste, accessories. Color: C2.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG1209761
• NIH Device Record Key: c9c8a7ed-d69b-4d46-95ee-31f34fca5835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaCrown
• Version Model Number: 120976
• Catalog Number: 120976
• 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 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG1209760 [Primary]
HIBCC	EDMG1209761 [Package]; Contains: EDMG1209760; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• POW: Crown And Bridge, Long-Term Temporary, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-18
• Device Publish Date: 2019-06-10

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