Dia-Pen

FDA UDI

Class I (US FDA UDI)

by DiaDent Group International

Identity

Trade Name: DIA-PEN FDA UDI
Generic Name: Endodontic obturation system FDA UDI
Device Name: Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system. FDA UDI
Model / Reference: DIA-PEN,PEN TIPS,FM FDA UDI
Description: Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system. FDA UDI

Identifiers

Catalog Number: 4002-1062 FDA UDI
Primary DI / UDI-DI: 08806383539029 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-Pen by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endodontic obturation system.

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elements IC — META SYSTEMS CO., LTD. · Class I
EndoPilot DownPack expansion set — Schlumbohm GmbH & Co. KG · Class I
B&L-Alpha II(P) — B&L Biotech 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: DiaDent Group International

Sources (1)

FDA UDI 59177dbe-32f7-44da-a3cd-ac164e8f2731 35 fields · synced May 30, 2026