LuxaCore® Smartmix Dual 212038

GUDID EDMG2120388

Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: Blue

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2120388
• NIH Device Record Key: 6568f1d8-ab02-49e3-8435-137283e4ce6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaCore® Smartmix Dual
• Version Model Number: 212038
• Catalog Number: 212038
• 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 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2120380 [Primary]
HIBCC	EDMG2120381 [Package]; Contains: EDMG2120380; Package: [2 Units]; In Commercial Distribution
HIBCC	EDMG2120388 [Package]; Contains: EDMG2120381; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012307

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 [LuxaCore® Smartmix Dual]

• EDMG2120648: Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @
• EDMG2120398: Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @
• EDMG2120388: Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @