LuxaCore® Z Dual - Core build-up composite with zirconium oxide and - DMG Chemisch-Pharmazeutische Fabrik GmbH

Duns Number:320744915

Device Description: Core build-up composite with zirconium oxide and nano technology. Feels like natural denti Core build-up composite with zirconium oxide and nano technology. Feels like natural dentine for precise preparation. Content: 1 cartridge @ 48 g paste, Accessories. Color: Blue

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More Product Details

Catalog Number

213331

Brand Name

LuxaCore® Z Dual

Version/Model Number

213331

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012307,K012307,K012307

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

40ac6069-68e6-485d-99bd-e086fdb97a54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

EDMG2133318

Quantity per Package

12

Contains DI Package

EDMG2133311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 143