Duns Number:124763728
Device Description: Atlas is the strongest high noble ceramic alloy that we offer. It solders well and does no Atlas is the strongest high noble ceramic alloy that we offer. It solders well and does not exhibit the brittleness that some technicians report with other medium-gold ceramic alloys
Catalog Number
-
Brand Name
Atlas White Ceramic Alloy
Version/Model Number
1060000
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
f8c8ed90-438e-4afd-921c-6873c8e8cd84
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 |