Friendo

FDA UDI

Class I (US FDA UDI)

by Dxm Co., Ltd

Identity

Trade Name: Friendo FDA UDI
Generic Name: Root canal obturation kit FDA UDI
Device Name: Lightest cordless warm vertical condensation device Effectively liquefies and condenses root canal filling materials 3 adjustable temperature settings Color-coded pen tips available in various sizes (XF, F, FM, M, ML) Excellent apical control over lateral and complicated root canals FDA UDI
Model / Reference: Friendo FDA UDI
Description: Lightest cordless warm vertical condensation device Effectively liquefies and condenses root canal filling materials 3 adjustable temperature settings Color-coded pen tips available in various sizes (XF, F, FM, M, ML) Excellent apical control over lateral and complicated root canals FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017900070 FDA UDI
FDA Product Code: EKR FDA UDI
GMDN Term: Root canal obturation kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Root canal obturation kit

Friendo by Dxm Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dxm Co., Ltd

Sources (1)

FDA UDI f95b1c73-9c53-4903-8c3e-7da9f29dfe01 34 fields · synced May 30, 2026