Duns Number:124763728
Device Description: Noble. A 6% gold alloy that produces a clean, very light oxide. Requiring no special pre-c Noble. A 6% gold alloy that produces a clean, very light oxide. Requiring no special pre-coating or acid cleanup. Pegasus casts exactly like a premium alloy. It has a high yield strength making it ideal for long spans. It casts accurately and the castings present no brittleness. With a relatively high thermal expansion, you will find it compatible with most of the major porcelains.
Catalog Number
-
Brand Name
Pegasus White Ceramic Alloy
Version/Model Number
1069906
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
K962302
Product Code
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
90eed1b1-31b7-468b-820a-4f81e9a65200
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 |