Duns Number:124763728
Device Description: High Noble. Silver free gold-palladium dental alloy eliminates "greening" effect with its
Catalog Number
-
Brand Name
Galaxy White Ceramic Alloy
Version/Model Number
1065225
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
K003007
Product Code
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
f2aa8ae7-bdbb-4f6d-a2cc-f13d6c75505c
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 |