Duns Number:448015938
Device Description: materials for inlays, onlays, crowns and bridges
Catalog Number
665756
Brand Name
IPS Empress CAD
Version/Model Number
665756
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
9eab58bc-b90e-44bb-95cb-25acee0e9709
Public Version Date
July 24, 2018
Public Version Number
3
DI Record Publish Date
December 07, 2016
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 | 131 |
2 | A medical device with a moderate to high risk that requires special controls. | 12768 |