HYBENX Advanced Dental Debridement Gel 109-0004

GUDID 00860004740322

HYBENX Advanced Dental Debridement is a 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.

Epien Medical, Inc.

Dental mouthwash
Primary Device ID00860004740322
NIH Device Record Key389fd3aa-48c9-45d5-b097-4e41325f154b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYBENX Advanced Dental Debridement Gel
Version Model Number109-0004
Catalog Number109-0004
Company DUNS128678765
Company NameEpien Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com
Phone6516533380
EmailKherland@epien.com

Device Dimensions

Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004740322 [Primary]

FDA Product Code

KJJCleanser, Root Canal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-17
Device Publish Date2023-05-09

Devices Manufactured by Epien Medical, Inc.

00860004740322 - HYBENX Advanced Dental Debridement Gel2023-05-17HYBENX Advanced Dental Debridement is a 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.
00860004740322 - HYBENX Advanced Dental Debridement Gel2023-05-17 HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth s
00860004740315 - HYBENX Advanced Dental Debridement2023-05-16 HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth sur
00860004740308 - HYBENX Root Canal Cleanser2021-05-28 EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces du

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