Duns Number:083235549
Device Description: Superdent® Pressure Indicator Paste - 2 oz. - 951-8604
Catalog Number
1421101FG
Brand Name
Superdent® Pressure Indicator Paste
Version/Model Number
1421101FG
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
-
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
EFH
Product Code Name
PAPER, ARTICULATION
Public Device Record Key
bb06ca60-aa18-476a-b978-24c759b675e6
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 21, 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 | 123 |
2 | A medical device with a moderate to high risk that requires special controls. | 397 |
U | Unclassified | 2 |