LuxaCore® Smartmix Dual 212064

GUDID EDMG2120648

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

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin
Primary Device IDEDMG2120648
NIH Device Record Key4100a527-a4af-4869-b05c-527487e4fcc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaCore® Smartmix Dual
Version Model Number212064
Catalog Number212064
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
HIBCCEDMG2120640 [Primary]
HIBCCEDMG2120641 [Package]
Contains: EDMG2120640
Package: [2 Units]
In Commercial Distribution
HIBCCEDMG2120648 [Package]
Contains: EDMG2120641
Package: [12 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® Smartmix Dual]

EDMG2120648Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @
EDMG2120398Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @
EDMG2120388Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @

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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