Endo@pex

FDA UDI

Class I (US FDA UDI)

by Dxm Co., Ltd

Identity

Trade Name: Endo@pex FDA UDI
Generic Name: Root canal obturation kit FDA UDI
Device Name: The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully delivers predictable results in vertical condensation and 3 dimensional thermo-plasticized obturation. The 2 most effective individual obturation device (Friendo, Gutta Easy) are beautifully combined as one convenient package for maximum efficiency FDA UDI
Model / Reference: Endo@pex FDA UDI
Description: The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully delivers predictable results in vertical condensation and 3 dimensional thermo-plasticized obturation. The 2 most effective individual obturation device (Friendo, Gutta Easy) are beautifully combined as one convenient package for maximum efficiency FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017900001 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

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

Similar devices

Also classified as Root canal obturation kit.

RE-GEN Bioactive EndoPutty Kit — Vista Dental · Class II
EndoCeramic Sealer — ENDO DIRECT, LLC · Class II
RE-GEN Bioactive EndoSealer — Vista Dental · Class II
REGEN Bioactive EndoSealer (SS MST Kit) — Vista Dental · Class II
EndoCeramic Root Repair Material — ENDO DIRECT, LLC · Class II
Gutta Easy — DXM CO., LTD · Class I
Friendo — DXM CO., LTD · Class I

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 89b3c388-0ccd-442c-95c5-12b99ca44c55 34 fields · synced Jun 8, 2026