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.
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
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
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 390 |