Duns Number:687789453
Device Description: DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine che DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.
Catalog Number
1003-202
Brand Name
DIA-PROSEAL
Version/Model Number
4g
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
K182009
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
19d6fc0f-9edf-4638-a129-5cf9b385c95e
Public Version Date
October 10, 2019
Public Version Number
1
DI Record Publish Date
October 02, 2019
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 |