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 1 Type ll Yellow Crown & Bridge Alloy
Version/Model Number
1127781
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2021
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
K022252
Product Code
EJS
Product Code Name
Alloy, Other Noble Metal
Public Device Record Key
20632994-e72d-4495-bcef-f340804b0c2b
Public Version Date
March 09, 2021
Public Version Number
6
DI Record Publish Date
February 16, 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 |