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Ezfil B3 9423

by Meta Biomed, Inc.

Model Ezfil A2, Ezfil A3, Ezfil B1, Ezfil A1, Ezfil D2, Ezfil B2, Ezfil C4, Ezfil D4, Ezfil B3

Ezfil B3 9423 is a device classified as Class IIa in the EU and Class II in the US made by Meta Biomed, Inc., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI B-08806387894179) and listed in FDA GUDID since 15 Mar 2020 (UDI-DI 08806387894230), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806387894179 Basic UDI-DI Date1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387894230 UDI-DI Date15 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806387894179 registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI 08806387894230 listed 15 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806387894230
  2. Registered EUDAMED B-08806387894179

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  • Withdrawn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
Ezfil EUDAMED
Ezfil B3 GUDID
Ezfil B1 GUDID
Ezfil D2 GUDID
Ezfil A3 GUDID
Ezfil D4 GUDID
Ezfil A1 GUDID
Ezfil B2 GUDID
Ezfil C4 GUDID
Ezfil A2 GUDID
Generic name
Dental composite resin
Model / reference
Ezfil A2 EUDAMED
Ezfil A3 EUDAMED
Ezfil B1 EUDAMED
Ezfil A1 EUDAMED
Ezfil D2 EUDAMED
Ezfil B2 EUDAMED
Ezfil C4 EUDAMED
Ezfil D4 EUDAMED
Ezfil B3 EUDAMED
9423 GUDID
9421 GUDID
9429 GUDID
9418 GUDID
9431 GUDID
9416 GUDID
9422 GUDID
9428 GUDID
9417 GUDID
Primary DI / UDI-DI
08806387894230, 08806387894216, 08806387894292, 08806387894186, 08806387894315, 08806387894162, 08806387894223, 08806387894285, 08806387894179
Basic UDI-DI
B-08806387894179, B-08806387894186, B-08806387894216, B-08806387894162, B-08806387894292, B-08806387894223, B-08806387894285, B-08806387894315, B-08806387894230
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Ezfil A2
Ezfil A3
Ezfil B1
Ezfil A1
Ezfil D2
Ezfil B2
Ezfil C4
Ezfil D4
Ezfil B3
GUDID
9423
9421
9429
9418
9431
9416
9422
9428
9417
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 Meta Biomed, Inc.

See all devices from Meta Biomed, Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)