Duns Number:124763728
Device Description: High Noble. Premium gold-palladium alloy. Auramic 210 is one of the first gold-palladium High Noble. Premium gold-palladium alloy. Auramic 210 is one of the first gold-palladium ceramic alloys. Strong and dependable, it is a good value and one of our best sellers. It contains silver, therefore, we recommend you maintain your porcelain furnace by regular purging.
Catalog Number
-
Brand Name
Auramic 210 White Ceramic Alloy
Version/Model Number
1065215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 03, 2020
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
57d92038-7613-4cbb-8c5f-b215cb440540
Public Version Date
September 04, 2020
Public Version Number
5
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 |