Duns Number:313214171
Device Description: DD Pro Shade C are liquids espacially for coloring pre-sintered white zirconia constructio DD Pro Shade C are liquids espacially for coloring pre-sintered white zirconia constructions made from DD cubeX² zirconia milling blanks for the manufacture of dental restorations.
Catalog Number
LPSC100A35
Brand Name
DD Pro Shade C
Version/Model Number
A3.5
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
7c578190-8d94-478b-a5ff-8b195d1d06be
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 09, 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 |