Duns Number:687789453
Device Description: DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal fil DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
Catalog Number
A1001-504
Brand Name
Diapex Plus
Version/Model Number
REFILL KIT
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182625
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
d75731dd-f89b-4404-b27a-93f508b387e4
Public Version Date
September 02, 2019
Public Version Number
1
DI Record Publish Date
August 23, 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 |