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HYBENX Root Canal Cleanser

FDA UDI

Class U (US FDA UDI)

by Epien Medical, Inc.

Identity

Trade Name
HYBENX Root Canal Cleanser FDA UDI
Generic Name
Dental mouthwash FDA UDI
Device Name
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. FDA UDI
Model / Reference
101-2002 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860004740308 FDA UDI
FDA Product Code
KJJ FDA UDI
GMDN Term
Dental mouthwash FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 2 Milliliter FDA UDI

HYBENX Root Canal Cleanser by Epien Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epien Medical, Inc.

Sources (1)

  • FDA UDI 03aeb177-f2bf-4e88-b7f1-c62186e23ef1 37 fields · synced Jun 6, 2026