Duns Number:124763728
Device Description: High Noble, Type II Premium alloy with excellent gold color. Micro-fine grain. Harder than High Noble, Type II Premium alloy with excellent gold color. Micro-fine grain. Harder than Sterngold S, it is better suited for MOD inlays. Casts into a highly aesthetic inlay and burnishes well.
Catalog Number
-
Brand Name
Sterngold® 2 - Type II Yellow Crown & Bridge Alloy
Version/Model Number
1127472
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
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
EJS
Product Code Name
Alloy, Other Noble Metal
Public Device Record Key
64fea5fa-b245-4ab6-9641-69d47eb617dd
Public Version Date
February 24, 2021
Public Version Number
2
DI Record Publish Date
May 27, 2020
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 |