Duns Number:128678765
Device Description: EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.
Catalog Number
-
Brand Name
HYBENX Root Canal Cleanser
Version/Model Number
101-2002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
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
K123538
Product Code
KJJ
Product Code Name
Cleanser, Root Canal
Public Device Record Key
03aeb177-f2bf-4e88-b7f1-c62186e23ef1
Public Version Date
July 20, 2022
Public Version Number
2
DI Record Publish Date
May 20, 2021
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 |
|---|---|---|
| U | Unclassified | 1 |