AccessGUDID - DEVICE: HYBENX Root Canal Cleanser (00860004740308)

GUDID

Device Identifier (DI) Information

Brand Name: HYBENX Root Canal Cleanser
Version or Model: 101-2002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Epien Medical, Inc.

Primary DI Number: 00860004740308
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 128678765 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42345	Dental mouthwash	A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJJ	Cleanser, Root Canal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 03aeb177-f2bf-4e88-b7f1-c62186e23ef1
Public Version Date: May 26, 2025
Public Version Number: 3
DI Record Publish Date: May 20, 2021