Duns Number:124763728
Device Description: Noble. Type III Good tarnish resistance with only 46% gold content. A moderately priced go Noble. Type III Good tarnish resistance with only 46% gold content. A moderately priced gold content alloy. You will find it to be your workhorse for crown and bridge alloy needs. With an excellent track record in terms of tarnish resistance, it can be used in all but the most reactive mouth situation.
Catalog Number
-
Brand Name
Sterngold® 10 - Type III Yellow Crown & Bridge Alloy
Version/Model Number
1126245
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
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
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
d8794851-32b5-49f4-9486-0d32e4886cc4
Public Version Date
March 09, 2021
Public Version Number
3
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 |