Tizian Blank Zirconia Reinforced Composite B2 - Milling blank made from high performance acrylic - Schütz Dental GmbH

Duns Number:315830349

Device Description: Milling blank made from high performance acrylic and zirconium dioxide which combines the Milling blank made from high performance acrylic and zirconium dioxide which combines the qualities of both materials. The elastic and mildly flexible material ensures permanent restorations with up to 3 units (single crowns, inlays, onlays, veneers, three-unit bridges) as well as long-term temporaries with up to 16 units and a life span of up to two years.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Tizian Blank Zirconia Reinforced Composite B2

Version/Model Number

220115

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

-

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

9561e6d0-f070-4ac7-a49e-cb3aa4316137

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHÜTZ DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 390