Duns Number:124763728
Device Description: Noble. 1.8% gold and 75.7% palladium, no silver. Columbus's low density and high strength Noble. 1.8% gold and 75.7% palladium, no silver. Columbus's low density and high strength make this an excellent choice for large spans. With a relatively high expansion it will be compatible with most porcelains.
Catalog Number
-
Brand Name
Columbus White Ceramic Alloy
Version/Model Number
1069900
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
-
Product Code
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
38384b70-08f3-4856-8239-f19897a0d1d0
Public Version Date
July 09, 2020
Public Version Number
4
DI Record Publish Date
March 10, 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 |