AccessGUDID - DEVICE: HYBENX Advanced Dental Debridement (00860004740315)

GUDID

Device Identifier (DI) Information

Brand Name: HYBENX Advanced Dental Debridement
Version or Model: 109-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 109-0001
Company Name: Epien Medical, Inc.

Primary DI Number: 00860004740315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 128678765 *Terms of Use

Device Description: HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.

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: 1.5 Milliliter

Device Record Status

Public Device Record Key: 2dc256d5-1ed3-48c8-93a7-6e348a792e9f
Public Version Date: May 16, 2023
Public Version Number: 1
DI Record Publish Date: May 08, 2023