Duns Number:124763728
Device Description: Noble. Palladium-silver alloy. A super economy ceramic alloy. More restorations have been Noble. Palladium-silver alloy. A super economy ceramic alloy. More restorations have been fabricated using Vista than any other precious Sterngold alloy. More than 2 million units in the mouth testify to its popularity. It casts and polishes like a conventional ceramic gold. Vista contains more than 60% noble metal and resists tarnishing on exposed surfaces.
Catalog Number
-
Brand Name
Vista White Ceramic Alloy
Version/Model Number
1060005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
3ba4d09c-22df-488f-a19b-719ae08f4100
Public Version Date
July 09, 2020
Public Version Number
4
DI Record Publish Date
March 10, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |