Gutta Easy

FDA UDI

Class I (US FDA UDI)

by Dxm Co., Ltd

Identity

Trade Name: Gutta Easy FDA UDI
Generic Name: Root canal obturation kit FDA UDI
Device Name: The Gutta Easy is the highly efficient gutta percha back fill obturation device. With its distinctive and inimitable features, the Gutta Easy makes thermo-plasticized root canal obturation much easier and faster than ever. The Gutta Easy's powerful and rapid heating control mechanisms delivers reliable and optimum clinical results. FDA UDI
Model / Reference: Gutta Easy FDA UDI
Description: The Gutta Easy is the highly efficient gutta percha back fill obturation device. With its distinctive and inimitable features, the Gutta Easy makes thermo-plasticized root canal obturation much easier and faster than ever. The Gutta Easy's powerful and rapid heating control mechanisms delivers reliable and optimum clinical results. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017900063 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

Gutta Easy 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 c613f6c3-eca0-4345-8571-a55be95b9951 34 fields · synced Jun 8, 2026