Duns Number:687789453
Device Description: Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
Catalog Number
A1001-401
Brand Name
DIAPASTE
Version/Model Number
Type A
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
K190091
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
0d60ab14-c770-4f4c-84f0-dafba6a8a50a
Public Version Date
May 01, 2020
Public Version Number
1
DI Record Publish Date
April 23, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |