LuxaFlow® Ultra 224003

GUDID EDMG2240031

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: A3

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2240031
• NIH Device Record Key: 1987989a-0462-46dd-b4bc-d8cde59832d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaFlow® Ultra
• Version Model Number: 224003
• Catalog Number: 224003
• 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	EDMG2240030 [Primary]
HIBCC	EDMG2240031 [Package]; Contains: EDMG2240030; Package: [2 Units]; In Commercial Distribution

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

On-Brand Devices [LuxaFlow® Ultra]

• EDMG2240051: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syring
• EDMG2240041: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syring
• EDMG2240031: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syring
• EDMG2240021: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syring
• EDMG2240011: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syring