Duns Number:313214171
Device Description: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations.
Catalog Number
LZS003
Brand Name
DD Bio ZX² monolith zero
Version/Model Number
SC1
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
43c9ff2f-aa85-4fd3-91df-c9953057d71d
Public Version Date
March 29, 2018
Public Version Number
2
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 |