Duns Number:313214171
Device Description: DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of denta DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio ZX² can be used for all dental constructions with up to two bridge elements in the front and side tooth area.
Catalog Number
G231003
Brand Name
DD Bio ZX² color
Version/Model Number
71H14 intense
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
94685c5d-2e6b-4dbd-85ff-aa2ef54cca33
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 |