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DenFil DF205-RA11

by Vericom Co., Ltd.

Ref DF205-RA11

DenFil DF205-RA11 is a dental composite resin (EU MDD Class IIa; FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Vericom Co., Ltd., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-08809254450607) and listed in FDA GUDID since 1 Nov 2016 (UDI-DI 08809254450607), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809254450607 Basic UDI-DI 08809254450607UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809254450607 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809254450607 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 08809254450607 listed 1 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809254450607
  2. Registered EUDAMED B-08809254450607

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
DenFil
Generic name
Dental composite resin
Device name
Light-cured composite resin
Model / reference
DF205-RA11
Primary DI / UDI-DI
08809254450607
Basic UDI-DI
B-08809254450607
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Vericom Co., Ltd.

See all devices from Vericom Co., Ltd. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)