Duns Number:526808191
Device Description: Cobalt-Chromium Partial Dental AlloyISO22674 Type 5Co63.0Cr30.0Mo5.0SiNi
Catalog Number
Stellite C3
Brand Name
Kennametal Stellite
Version/Model Number
Stellite C3
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
93a040e7-dc73-4459-bb7e-567776ee082f
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
Package DI Number
06972796430030
Quantity per Package
20
Contains DI Package
06972796430016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton