LuxaCore® Automix Dual 212127

GUDID EDMG2121271

Core cuild-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 ml paste, Accessories. Color: White.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin
Primary Device IDEDMG2121271
NIH Device Record Key48c58e80-fd0e-45a2-92eb-89a2f427525f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaCore® Automix Dual
Version Model Number212127
Catalog Number212127
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2121270 [Primary]
HIBCCEDMG2121271 [Package]
Contains: EDMG2121270
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [LuxaCore® Automix Dual]

EDMG2121271Core cuild-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @
EDMG2121268Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge 5
EDMG2120581Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @
EDMG2120128Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @
EDMG2120118Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @

Trademark Results [LuxaCore]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUXACORE
LUXACORE
75569945 2358634 Live/Registered
ERNST MUHLBAUER GMBH & CO, KG
1998-10-14

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