Dia-Gun

FDA UDI

Class I (US FDA UDI)

by DiaDent Group International

Identity

Trade Name: DIA-GUN FDA UDI
Generic Name: Endodontic obturation system FDA UDI
Device Name: Dia-Gun is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. FDA UDI
Model / Reference: DIA-GUN,DISPOSABLE GUN TIPS,25G FDA UDI
Description: Dia-Gun is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. FDA UDI

Identifiers

Catalog Number: 4001-1071 FDA UDI
Primary DI / UDI-DI: 08806383535779 FDA UDI
FDA Product Code: EKR FDA UDI
GMDN Term: Endodontic obturation system 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

Yes

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 obturation system

Dia-Gun by DiaDent Group International — 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: DiaDent Group International

Sources (1)

FDA UDI f9ec343d-3920-4b13-ae2f-4b994f009946 35 fields · synced May 30, 2026