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DIAFIL & DIAFIL Capsule

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K192510Ref A2001-1101EUModel DIAFIL START KIT A SETRef A2001-1502Model DIAFIL Intro Kit A2Ref A2001-1510Model DIAFIL Intro Kit B3Ref A2001-1402Model DIAFIL Capsule Type A3Ref A2001-1508Model DIAFIL Intro Kit B1Ref A2001-1401Model DIAFIL Capsule Type A2Ref A2001-1403Model DIAFIL Capsule Type A3.5Ref A2001-1505Model DIAFIL Intro Kit A3ORef A2001-1509Model DIAFIL Intro Kit B2Ref A2001-1503Model DIAFIL Intro Kit A2ORef A2001-1212Model DIAFIL Refill Package A2ORef A2001-1404Model DIAFIL Capsule Type B2Ref A2001-1204Model DIAFIL Refill Package A3.5Ref A2001-1207Model DIAFIL Refill Package B2Ref A2001-1103EUModel DIAFIL START KIT C SETRef A2001-1405Model DIAFIL Capsule Type A1Ref A2001-1504Model DIAFIL Intro Kit A3Ref A2001-1205Model DIAFIL Refill Package A4Ref A2001-1514Model DIAFIL Intro Kit C3

by Diadent Group International

Identity

Trade Name
DIAFIL EUDAMEDFDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
DIAFIL EUDAMED
DiaFil & DiaFil Capsule is a composite resin for esthetic restorative. FDA UDI
Model / Reference
DIAFIL START KIT A SET EUDAMED
A2001-1101EU EUDAMED
DIAFIL Intro Kit A2 EUDAMED
A2001-1502 EUDAMED
DIAFIL Intro Kit B3 EUDAMED
A2001-1510 EUDAMED
DIAFIL Capsule Type A3 EUDAMED
A2001-1402 EUDAMED
DIAFIL Intro Kit B1 EUDAMED
A2001-1508 EUDAMED
DIAFIL Capsule Type A2 EUDAMED
A2001-1401 EUDAMED
DIAFIL Capsule Type A3.5 EUDAMED
A2001-1403 EUDAMED
DIAFIL Intro Kit A3O EUDAMED
A2001-1505 EUDAMED
DIAFIL Intro Kit B2 EUDAMED
A2001-1509 EUDAMED
DIAFIL Intro Kit A2O EUDAMED
A2001-1503 EUDAMED
DIAFIL Refill Package A2O EUDAMED
A2001-1212 EUDAMED
DIAFIL Capsule Type B2 EUDAMED
A2001-1404 EUDAMED
DIAFIL Refill Package A3.5 EUDAMED
A2001-1204 EUDAMED
DIAFIL Refill Package B2 EUDAMED
A2001-1207 EUDAMED
DIAFIL START KIT C SET EUDAMED
A2001-1103EU EUDAMED
DIAFIL Capsule Type A1 EUDAMED
A2001-1405 EUDAMED
DIAFIL Intro Kit A3 EUDAMED
A2001-1504 EUDAMED
DIAFIL Refill Package A4 EUDAMED
A2001-1205 EUDAMED
DIAFIL Intro Kit C3 EUDAMED
A2001-1514 EUDAMED
Intro Kit B2 FDA UDI
Refill A3.5 FDA UDI
Capsure Type A3.5 FDA UDI
Intro Kit B3 FDA UDI
Intro Kit B1 FDA UDI
Refill A2O FDA UDI
Intro Kit A2O FDA UDI
Refill B2 FDA UDI
Capsure Type A3 FDA UDI
Intro Kit A3O FDA UDI
Intro Kit A2 FDA UDI
Capsure Type A1 FDA UDI
Intro Kit A3 FDA UDI
Refill A4 FDA UDI
Capsure Type A2 FDA UDI
Capsure Type B2 FDA UDI
Intro Kit C3 FDA UDI
Description
DiaFil & DiaFil Capsule is a composite resin for esthetic restorative. FDA UDI

Identifiers

Catalog Number
A2001-1509 FDA UDI
A2001-1204 FDA UDI
A2001-1403 FDA UDI
A2001-1510 FDA UDI
A2001-1508 FDA UDI
A2001-1212 FDA UDI
A2001-1503 FDA UDI
A2001-1207 FDA UDI
A2001-1402 FDA UDI
A2001-1505 FDA UDI
A2001-1502 FDA UDI
A2001-1405 FDA UDI
A2001-1504 FDA UDI
A2001-1205 FDA UDI
A2001-1401 FDA UDI
A2001-1404 FDA UDI
A2001-1514 FDA UDI
Primary DI / UDI-DI
08806383575690 EUDAMEDFDA UDI
08806383564946 EUDAMEDFDA UDI
08806383565110 EUDAMEDFDA UDI
08806383575706 EUDAMEDFDA UDI
08806383575683 EUDAMEDFDA UDI
08806383565028 EUDAMEDFDA UDI
08806383575638 EUDAMEDFDA UDI
08806383564977 EUDAMEDFDA UDI
08806383565103 EUDAMEDFDA UDI
08806383575669 EUDAMEDFDA UDI
08806383575621 EUDAMEDFDA UDI
08806383565134 EUDAMEDFDA UDI
08806383575645 EUDAMEDFDA UDI
08806383564953 EUDAMEDFDA UDI
08806383565097 EUDAMEDFDA UDI
08806383565127 EUDAMEDFDA UDI
08806383575720 EUDAMEDFDA UDI
08806383586641 EUDAMED
08806383586665 EUDAMED
Basic UDI-DI
B-08806383586641 EUDAMED
B-08806383575621 EUDAMED
B-08806383575706 EUDAMED
B-08806383565103 EUDAMED
B-08806383575683 EUDAMED
B-08806383565097 EUDAMED
B-08806383565110 EUDAMED
B-08806383575669 EUDAMED
B-08806383575690 EUDAMED
B-08806383575638 EUDAMED
B-08806383565028 EUDAMED
B-08806383565127 EUDAMED
B-08806383564946 EUDAMED
B-08806383564977 EUDAMED
B-08806383586665 EUDAMED
B-08806383565134 EUDAMED
B-08806383575645 EUDAMED
B-08806383564953 EUDAMED
B-08806383575720 EUDAMED
510(k) Number
K192510 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

The DiaFil and DiaFil Capsule are light-cured nanohybrid composite dental restorative materials. These devices are designed to restore dental cavities by providing a durable, aesthetically pleasing filling that combines the strength of hybrid composites with the refined appearance of microfilled materials, ensuring long-term clinical performance.

DiaFil and DiaFil Capsule are supplied as single-use, non-sterile dental materials intended for use in clinical settings by dental professionals. They are available in capsule form for easy handling and application, with no specific regulatory mention of MRI safety or sterility requirements in the provided data. Authorized under FDA 510(k) clearance and MDD compliance, these devices are classified under product code EBF for dental restorative materials.

Frequently asked questions

What types of dental cavities are these materials intended to restore, and how do they differ from traditional fillings?

DiaFil and DiaFil Capsule are designed to restore dental cavities by filling and sealing them with a durable, nanohybrid composite material. Unlike traditional fillings, these materials combine the strength of hybrid composites with the refined, natural appearance of microfilled materials, providing both longevity and aesthetic appeal. They are specifically formulated for clinical use by dental professionals to ensure long-term clinical performance and a more lifelike restoration.

Are DiaFil and DiaFil Capsule single-use or reusable, and how should they be handled in a clinical setting?

DiaFil and DiaFil Capsule are supplied as single-use materials, meaning each capsule is intended for one application only. Since they are non-sterile, they should be handled in a clinical setting with standard dental hygiene practices to prevent contamination. The capsule form ensures easy and precise handling during application, reducing the risk of material waste or cross-contamination.

What forms do DiaFil and DiaFil Capsule come in, and how does the capsule format benefit the user?

DiaFil and DiaFil Capsule are supplied exclusively in capsule form, which simplifies the application process for dental professionals. The capsules contain pre-measured amounts of the composite material, ensuring consistency in dosage and reducing the chance of errors during mixing or application. This format also minimizes waste and makes the material easier to integrate into existing dental workflows.

How should DiaFil and DiaFil Capsule be stored, and are there any special considerations for their shelf life?

Since the provided data does not specify storage instructions, DiaFil and DiaFil Capsule should generally be stored in a cool, dry place away from direct sunlight, as is standard practice for dental composites. As single-use materials, they should be kept in their original packaging until ready for use to maintain their integrity. Always follow the manufacturer’s guidelines if additional storage instructions are provided elsewhere.

What regulatory pathways have been followed for DiaFil and DiaFil Capsule, and how does this affect their use in clinical settings?

DiaFil and DiaFil Capsule have undergone FDA 510(k) clearance and comply with the Medical Devices Directive (MDD), confirming their substantial equivalence to existing dental restorative materials. This regulatory clearance ensures they meet safety, performance, and manufacturing standards required for clinical use in dental settings. The classification under product code EBF (dental restorative materials) further confirms their intended purpose for cavity restoration.

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 (Capsules) Light-Cured Nanohybrid Composites - DiaDent, DIAFIL, DiaFil (Capsule) (Diadent) | Dental Product | Pearson Dental, DiaFil | DiaDent | Darby Dental

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 (37)

  • FDA 510(k) K192510 24 fields · synced Sep 18, 2026
  • FDA UDI b496948e-eb40-4cc2-8aae-f594d3f19f9e 35 fields · synced May 26, 2026
  • FDA UDI 78b266b9-a3ac-42e9-8f2a-edb415824bcd 35 fields · synced May 29, 2026
  • FDA UDI a877a42a-bb27-443b-b1fe-eddc48b99feb 35 fields · synced May 29, 2026
  • FDA UDI 440bb7af-77c1-401e-af73-889ceaccd86e 35 fields · synced May 30, 2026
  • FDA UDI 1b32a869-5afd-4cd6-99fc-65bf9a45af95 35 fields · synced May 30, 2026
  • FDA UDI 6c5ebb74-47c3-49c8-81a7-7244e45f3a77 35 fields · synced May 30, 2026
  • FDA UDI de024997-c8eb-4b9c-aebc-a238bb0c2f17 35 fields · synced May 30, 2026
  • FDA UDI 548765f7-34d4-4ffe-8f6c-f500561abace 35 fields · synced May 30, 2026
  • FDA UDI b3dd644a-c5a8-4384-8ab0-24c96830ff2d 35 fields · synced May 30, 2026
  • FDA UDI 79ea74e7-f903-41d6-91c9-9027c9b43470 35 fields · synced May 30, 2026
  • FDA UDI 3cd56167-3a44-4b71-ba0a-32a55b85553c 35 fields · synced May 30, 2026
  • FDA UDI 427ea209-8cbc-42dd-9817-dcdf7d649883 35 fields · synced May 30, 2026
  • FDA UDI 4f9853e5-d739-4156-9856-796b79f5749f 35 fields · synced May 30, 2026
  • FDA UDI 86ee511f-cfa3-4e32-9284-4a141f15d59c 35 fields · synced May 30, 2026
  • FDA UDI b0deb391-3abf-4594-bc34-0a5a2fd6b760 35 fields · synced May 30, 2026
  • FDA UDI 29931f40-025f-4b7b-a24b-2739abb01ea6 35 fields · synced May 30, 2026
  • FDA UDI 2499b630-4fa2-4452-aa7c-6b03bb9c4d57 35 fields · synced May 30, 2026
  • EUDAMED c9ff9829-4323-4e27-b752-f1986f439d4f 61 fields · synced Jun 20, 2026
  • EUDAMED 8991d092-5a21-4389-ae3b-1757ca4ea5a0 61 fields · synced Jul 9, 2026
  • EUDAMED c62455bb-41b9-402a-80ff-8198957a16b1 61 fields · synced Jul 9, 2026
  • EUDAMED cc7c31b8-f733-4c06-962c-e79adf57d853 61 fields · synced Jul 9, 2026
  • EUDAMED 2d630ee8-c74a-4fd8-b4e6-541efabd325a 61 fields · synced Jul 10, 2026
  • EUDAMED c5392f83-5c29-42c2-ab5c-8e8aa75292a5 61 fields · synced Jul 13, 2026
  • EUDAMED ccf2b5f1-04cf-45da-a2e9-5b5304b7ef76 61 fields · synced Jul 15, 2026
  • EUDAMED 43345fa0-6712-4109-988b-8207827d7981 61 fields · synced Jul 15, 2026
  • EUDAMED ab065677-05fb-44d5-888e-104ac6c35bc8 61 fields · synced Jul 17, 2026
  • EUDAMED e5be6214-9b0f-42c5-9b34-04a2331ea97f 61 fields · synced Jul 19, 2026
  • EUDAMED a8cd8d8f-3005-45cb-bf4b-8a3e40fe4f94 61 fields · synced Jul 21, 2026
  • EUDAMED 53383580-be66-4f88-84e5-0ab30693a45d 61 fields · synced Jul 21, 2026
  • EUDAMED c059fd22-4e6c-452d-b61d-f9a7cc565610 61 fields · synced Jul 25, 2026
  • EUDAMED 46574e45-8321-40cc-b8c6-c31dae298f38 61 fields · synced Jul 26, 2026
  • EUDAMED 804e88e6-970f-408e-b0d9-e3276533268d 61 fields · synced Jul 26, 2026
  • EUDAMED 2aa26db6-7777-48d9-93f4-52882d50c0f3 61 fields · synced Jul 28, 2026
  • EUDAMED e73d7b9a-bf91-44fe-b08b-70da25736857 61 fields · synced Jul 29, 2026
  • EUDAMED 0817ee35-a8f8-42c6-ba45-126ad7075954 61 fields · synced Aug 1, 2026
  • EUDAMED 07f5eb02-8d89-4a95-b87d-e05dd8173589 61 fields · synced Aug 2, 2026