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DiaFil Flow

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K192284Ref A2001-4109Model DIAFIL FLOW Economic Package A3ORef A2001-4102Model DIAFIL FLOW Economic Package A2Ref A2001-4304Model DIAFIL FLOW Intro Kit A3Ref A2001-4205Model DIAFIL FLOW Refill Package B2Ref A2001-4108Model DIAFIL FLOW Economic Package A2ORef A2001-4105Model DIAFIL FLOW Economic Package B2Ref A2001-4106Model DIAFIL FLOW Economic Package B3Ref A2001-4209Model DIAFIL FLOW Refill Package A3ORef A2001-4302Model DIAFIL FLOW Intro Kit A2Ref A2001-4204Model DIAFIL FLOW Refill Package A3.5Ref A2001-4101Model DIAFIL FLOW Economic Package A1Ref A2001-4309Model DIAFIL FLOW Intro Kit B2Ref A2001-4107Model DIAFIL FLOW Economic Package C2Ref A2001-4201Model DIAFIL FLOW Refill Package A1

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 Economic Package A3O EUDAMED
A2001-4109 EUDAMED
DIAFIL FLOW Economic Package A2 EUDAMED
A2001-4102 EUDAMED
DIAFIL FLOW Intro Kit A3 EUDAMED
A2001-4304 EUDAMED
DIAFIL FLOW Refill Package B2 EUDAMED
A2001-4205 EUDAMED
DIAFIL FLOW Economic Package A2O EUDAMED
A2001-4108 EUDAMED
DIAFIL FLOW Economic Package B2 EUDAMED
A2001-4105 EUDAMED
DIAFIL FLOW Economic Package B3 EUDAMED
A2001-4106 EUDAMED
DIAFIL FLOW Refill Package A3O EUDAMED
A2001-4209 EUDAMED
DIAFIL FLOW Intro Kit A2 EUDAMED
A2001-4302 EUDAMED
DIAFIL FLOW Refill Package A3.5 EUDAMED
A2001-4204 EUDAMED
DIAFIL FLOW Economic Package A1 EUDAMED
A2001-4101 EUDAMED
DIAFIL FLOW Intro Kit B2 EUDAMED
A2001-4309 EUDAMED
DIAFIL FLOW Economic Package C2 EUDAMED
A2001-4107 EUDAMED
DIAFIL FLOW Refill Package A1 EUDAMED
A2001-4201 EUDAMED
Economic Package B3 FDA UDI
Intro Kit A2 FDA UDI
Economic Package B2 FDA UDI
Refill Package A3.5 FDA UDI
Refill Package A3O FDA UDI
Intro Kit A3 FDA UDI
Economic Package C2 FDA UDI
Economic Package A3O FDA UDI
Refill Package B2 FDA UDI
Economic Package A2 FDA UDI
Refill Package A1 FDA UDI
Economic Package A2O FDA UDI
Intro Kit B2 FDA UDI
Economic Package A1 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
A2001-4106 FDA UDI
A2001-4302 FDA UDI
A2001-4105 FDA UDI
A2001-4204 FDA UDI
A2001-4209 FDA UDI
A2001-4304 FDA UDI
A2001-4107 FDA UDI
A2001-4109 FDA UDI
A2001-4205 FDA UDI
A2001-4102 FDA UDI
A2001-4201 FDA UDI
A2001-4108 FDA UDI
A2001-4309 FDA UDI
A2001-4101 FDA UDI
Primary DI / UDI-DI
08806383565264 EUDAMEDFDA UDI
08806383576284 EUDAMEDFDA UDI
08806383565257 EUDAMEDFDA UDI
08806383565509 EUDAMEDFDA UDI
08806383565554 EUDAMEDFDA UDI
08806383576307 EUDAMEDFDA UDI
08806383565271 EUDAMEDFDA UDI
08806383565295 EUDAMEDFDA UDI
08806383565516 EUDAMEDFDA UDI
08806383565226 EUDAMEDFDA UDI
08806383565479 EUDAMEDFDA UDI
08806383565288 EUDAMEDFDA UDI
08806383576352 EUDAMEDFDA UDI
08806383565219 EUDAMEDFDA UDI
Basic UDI-DI
B-08806383565295 EUDAMED
B-08806383565226 EUDAMED
B-08806383576307 EUDAMED
B-08806383565516 EUDAMED
B-08806383565288 EUDAMED
B-08806383565257 EUDAMED
B-08806383565264 EUDAMED
B-08806383565554 EUDAMED
B-08806383576284 EUDAMED
B-08806383565509 EUDAMED
B-08806383565219 EUDAMED
B-08806383576352 EUDAMED
B-08806383565271 EUDAMED
B-08806383565479 EUDAMED
510(k) Number
K192284 FDA 510(k)
FDA Product Code
EBF FDA 510(k)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 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)FDA UDI
Market of Registration
Netherlands EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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 is a flowable composite resin, classified under dental restorative materials, designed for minimally invasive restorative procedures in dentistry. It is formulated to provide high strength, minimal shrinkage, and consistent handling for applications such as Class III, V, shallow Class IV restorations, air abrasion preparations, and tunnel restorations. The material also serves as a base or liner under posterior restorations and can repair small defects in esthetic indirect restorations, including composite and ceramic surfaces. Its composition ensures durability and compatibility with standard dental curing protocols.

DiaFil Flow is supplied as a single-use, light-cured dental composite resin intended for use in clinical settings by dental professionals. The product adheres to FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). It is packaged for ease of use in dental offices, with no specified sterility requirements beyond standard dental practice protocols. The material is non-magnetic and safe for use in non-MRI environments. No additional regulatory approvals beyond those stated are implied.

Frequently asked questions

What types of dental restorations is DiaFil Flow specifically designed for, and why is this important for clinicians?

DiaFil Flow is formulated for minimally invasive procedures like Class III, V, shallow Class IV restorations, air abrasion preparations, and tunnel restorations. It also serves as a base or liner under posterior restorations and can repair small defects in esthetic indirect restorations, including composite and ceramic surfaces. This versatility is important for clinicians because it reduces the need for multiple materials and allows for precise, durable restorations with minimal tooth structure removal, aligning with modern conservative dentistry approaches.

Is DiaFil Flow intended for single-use or can it be reused? How does this affect clinical workflow?

DiaFil Flow is explicitly supplied as a single-use product, meaning each package is designed for one application. This design choice ensures sterility consistency and eliminates cross-contamination risks, which is critical in clinical settings where infection control is paramount. Clinicians should open a new package for each patient to maintain workflow efficiency and compliance with dental practice protocols.

What curing method does DiaFil Flow require, and how does this integrate with standard dental office equipment?

DiaFil Flow is a light-cured composite resin, meaning it requires activation via a standard dental curing light (e.g., halogen, LED, or plasma arc). Its formulation is compatible with conventional curing protocols, so no additional equipment is needed beyond what most dental offices already use. This ensures seamless integration into existing workflows without requiring specialized tools.

Are there any special storage requirements for DiaFil Flow, and how should it be handled to maintain its performance?

DiaFil Flow does not specify unique sterility requirements beyond standard dental practice protocols, but it should be stored according to general guidelines for dental composites: protected from light, moisture, and extreme temperatures. The packaging is designed for clinical use, so it should remain sealed until use. Proper storage ensures the material retains its handling properties and curing performance, as prolonged exposure to environmental factors could degrade its consistency.

What regulatory pathways does DiaFil Flow follow, and what does this mean for clinicians or purchasers?

DiaFil Flow is cleared under the FDA 510(k) Traditional pathway (K192284) and complies with the Medical Device Directive (MDD). This means the product has undergone evaluation to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards. For clinicians or purchasers, this indicates the material has undergone rigorous review by regulatory authorities, validating its suitability for clinical use in dental restorative procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DiaFil Flow - Flowable Composite - DiaDent, DiaFil™ Bulk Flow - Light Cured Single Shade Bulk Fill Flowable Resin, DiaFil Flow - Diadent Europe

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diadent Group International

Sources (29)

  • FDA 510(k) K192284 24 fields · synced Sep 20, 2026
  • FDA UDI 62b00005-6cd3-44c0-a758-de6924b20ca1 35 fields · synced May 29, 2026
  • FDA UDI 2e5fae46-f243-4c4d-bc60-7eb3088f5a8f 35 fields · synced May 29, 2026
  • FDA UDI c3410463-ba7a-4246-a376-9e7d3e3ddb72 35 fields · synced May 30, 2026
  • FDA UDI 9d23e533-91e5-4956-be81-e4d96fd9a924 35 fields · synced May 30, 2026
  • FDA UDI 43390397-fa8c-4150-90d5-a8720a298ae1 35 fields · synced May 30, 2026
  • FDA UDI 33610c47-de9a-4821-bd43-5621e564a4c4 35 fields · synced May 30, 2026
  • FDA UDI 0d0f5f73-aff5-4c5d-b21a-1dc21ac79310 35 fields · synced May 30, 2026
  • FDA UDI 165523b9-06ef-4f30-9575-f5b5b9c72fb6 35 fields · synced May 30, 2026
  • FDA UDI 4d5ebf83-1fd7-4481-820f-f68e73b8300a 35 fields · synced May 30, 2026
  • FDA UDI e61f38fe-84c6-402f-98d5-69513328341f 35 fields · synced May 30, 2026
  • FDA UDI 4dfda1c3-e4bd-4758-af2a-0bbf95901db0 35 fields · synced May 30, 2026
  • FDA UDI 4712ac8f-4684-4bb8-aa4f-c42de651bd85 35 fields · synced May 30, 2026
  • FDA UDI 40664970-144d-4722-adef-2d9fc08ec72e 35 fields · synced May 30, 2026
  • FDA UDI 1960f34e-ba86-40a5-9c0d-24a867b5b8a1 35 fields · synced May 30, 2026
  • EUDAMED ea7d077b-3afb-4753-8e87-380abe759811 61 fields · synced Jul 8, 2026
  • EUDAMED ac1eff37-10b7-4051-be65-fcdaab3e8f47 61 fields · synced Jul 10, 2026
  • EUDAMED 29628cf0-eb73-4f24-ba17-69f72d5202e4 61 fields · synced Jul 11, 2026
  • EUDAMED 0457a652-f8af-43fb-bb22-dd5bff50ee74 61 fields · synced Jul 12, 2026
  • EUDAMED 4bf79ba7-791c-4d9d-8fae-bedd6f108c9e 61 fields · synced Jul 13, 2026
  • EUDAMED 922b8069-b599-4224-b29b-d56324ac6c34 61 fields · synced Jul 15, 2026
  • EUDAMED b0af1e71-8b2d-4cc9-b8eb-2bd54f74a9a7 61 fields · synced Jul 15, 2026
  • EUDAMED 6873bfc0-4d05-4663-a919-a92b42158f8d 61 fields · synced Jul 16, 2026
  • EUDAMED 8cebd7fe-68a7-4aff-bd65-70b870a264c4 61 fields · synced Jul 21, 2026
  • EUDAMED e62f3366-de57-4fa3-b989-a65591ca97e0 61 fields · synced Jul 23, 2026
  • EUDAMED e2f02d44-2cb0-4348-888d-11ff998f8069 61 fields · synced Jul 27, 2026
  • EUDAMED ef2c8121-7344-41ef-923c-d49aea67a784 61 fields · synced Jul 30, 2026
  • EUDAMED 643583b3-c6e3-45b7-a241-609bd598a0c2 61 fields · synced Aug 1, 2026
  • EUDAMED e4a59909-3e1a-4c15-be13-8eb57eaeae1d 61 fields · synced Sep 17, 2026