HYBENX Root Canal Cleanser

GUDID 00860004740308

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.

Epien Medical, Inc.

Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash
Primary Device ID00860004740308
NIH Device Record Key03aeb177-f2bf-4e88-b7f1-c62186e23ef1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYBENX Root Canal Cleanser
Version Model Number101-2002
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
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com
Phone6516533380
Emailcustomerservice@epien.com

Device Dimensions

Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004740308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-05-28
Device Publish Date2021-05-20

Devices Manufactured by Epien Medical, Inc.

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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 Cleanser2021-05-28EPIEN 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.
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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