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DiaFil Flow

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref A2001-4309Model DIAFIL FLOW Intro Kit B2

by DiaDent Group International

Identity

Trade Name
DiaFil Flow EUDAMEDFDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
DIAFIL FLOW EUDAMED
The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. FDA UDI
Model / Reference
DIAFIL FLOW Intro Kit B2 EUDAMED
A2001-4309 EUDAMED
Intro Kit B2 FDA UDI
Description
The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. FDA UDI

Identifiers

Catalog Number
A2001-4309 FDA UDI
Primary DI / UDI-DI
08806383576352 EUDAMEDFDA UDI
Basic UDI-DI
B-08806383576352 EUDAMED
FDA Product Code
EBF FDA UDI
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DiaFil Flow by DiaDent Group International — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaDent Group International

Sources (2)

  • FDA UDI 40664970-144d-4722-adef-2d9fc08ec72e 35 fields · synced Oct 7, 2026
  • EUDAMED ef2c8121-7344-41ef-923c-d49aea67a784 61 fields · synced Jul 30, 2026