LuxaFlow® Ultra Intro Kit 224000

GUDID EDMG2240001

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 4 syringes @ 1,5 g composite, Accessories. Colors: A1, A2, A3.5, B1

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2240001
• NIH Device Record Key: c54b1351-4132-4c5b-96d6-d85f18fb9469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaFlow® Ultra Intro Kit
• Version Model Number: 224000
• Catalog Number: 224000
• 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: true
• 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	EDMG2240001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011211

FDA Product Code

• EBF: Material, Tooth Shade, 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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