Duns Number:313214171
Device Description: High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduc High translucent zirconia for the manufacture of monolithic or for ceramic veneering reduced partial or single crowns, bridges with up to 3 units (anterior and posterior region), inlays / onlays and veneers for dental application.
Catalog Number
G712008
Brand Name
DD cubeX² color
Version/Model Number
98H14 A4
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
Yes
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
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
a499b07e-0d8e-4dd4-bdb7-d6866c95b0e3
Public Version Date
July 24, 2018
Public Version Number
3
DI Record Publish Date
October 05, 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. | 677 |