DX-Condenser

FDA UDI

Class I (US FDA UDI)

by Dxm Co., Ltd

Identity

Trade Name: DX-Condenser FDA UDI
Generic Name: Endodontic plugger FDA UDI
Device Name: Nickel titanium and a stainless-steel end. Can be used in any common obturation technique, including warm and cold condensation. Excellent tactile sense and durability. FDA UDI
Model / Reference: Set FDA UDI
Description: Nickel titanium and a stainless-steel end. Can be used in any common obturation technique, including warm and cold condensation. Excellent tactile sense and durability. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017900223 FDA UDI
FDA Product Code: EKR FDA UDI
GMDN Term: Endodontic plugger 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic plugger

DX-Condenser 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 ad296b70-2e2b-4cf7-a872-3fa712a6b991 33 fields · synced Jun 8, 2026