Duns Number:124763728
Device Description: Non-Precious Ceramic Alloy Beta is an easy to cast nickel chrome alloy. Unlike many non-pr Non-Precious Ceramic Alloy Beta is an easy to cast nickel chrome alloy. Unlike many non-precious alloys, Beta requires no metal conditioner or bonding agent and it polishes to a high shine.
Catalog Number
-
Brand Name
Beta (5oz) - Type V Non-Precious Ceramic Alloy
Version/Model Number
5052225
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
567a5568-ce77-4daa-a569-5a7a0a867dbc
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 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 |