Duns Number:073944274
Device Description: VeraSoft, Dental casting non-noble alloy
Catalog Number
-
Brand Name
VeraSoft
Version/Model Number
VS
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
K925579
Product Code
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
819f7f37-0730-4953-834c-8b0710112834
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 08, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 41 |