DiaFlex

FDA UDI

Class I (US FDA UDI)

by DiaDent Group International

Identity

Trade Name: DiaFlex FDA UDI
Generic Name: Dental irrigation/aspiration syringe FDA UDI
Device Name: Syringe for root canal irrigation FDA UDI
Model / Reference: TYPE V FDA UDI
Description: Syringe for root canal irrigation FDA UDI

Identifiers

Catalog Number: 1003-501 FDA UDI
Primary DI / UDI-DI: 08806383500289 FDA UDI
FDA Product Code: EIC FDA UDI
GMDN Term: Dental irrigation/aspiration syringe 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: Dental irrigation/aspiration syringe

DiaFlex by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental irrigation/aspiration syringe.

Vivid HypoJect 3cc — PEARSON DENTAL SUPPLIES, INC. · Class II
American Eagle Instruments — American Eagle Instruments · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
CLEARJET AIR WATER SYRINGE TIPS 250/bag STD 76mm CLEAR — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
CanalPro — Coltene/Whaledent Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: DiaDent Group International

Sources (1)

FDA UDI 78e5a728-2264-4d66-acac-c2e9528ef4a2 35 fields · synced May 30, 2026