Duns Number:124763728
Device Description: This versatile, low-cost alloy has proven itself in millions of units for almost 4 decades This versatile, low-cost alloy has proven itself in millions of units for almost 4 decades. However, with it's low nobility composition, we would not recommend it for patients with highly re-active mouths.
Catalog Number
-
Brand Name
Sterngold 66 Type lll White Crown & Bridge Alloy
Version/Model Number
1180229
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
K021367
Product Code
EJS
Product Code Name
Alloy, Other Noble Metal
Public Device Record Key
9ddb3934-2169-4ee3-8e96-8d49bdaa1716
Public Version Date
July 09, 2020
Public Version Number
5
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 |