LuxaCore® Z Dual 213334

GUDID EDMG2133348

Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 2 syringes @ 9 g paste, Accessories. Color: A3

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin
Primary Device IDEDMG2133348
NIH Device Record Keyf0880837-0a1b-41ef-b168-8b60a8a19a6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaCore® Z Dual
Version Model Number213334
Catalog Number213334
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
HIBCCEDMG2133340 [Primary]
HIBCCEDMG2133341 [Package]
Contains: EDMG2133340
Package: [2 Units]
In Commercial Distribution
HIBCCEDMG2133348 [Package]
Contains: EDMG2133341
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® Z Dual]

EDMG2133368Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for
EDMG2133358Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for
EDMG2133348Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for
EDMG2133328Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for
EDMG2133318Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for
EDMG2133308Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.