Skip to content

Admira 2454

by VOCO GmbH

Ref 2454Model caps

Admira 2454 is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI B-E22124541), cleared under FDA 510(k) K061823 on 21 Jul 2006 (1 earlier submission) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22124541), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061823

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-E22124541 Basic UDI-DI E22124541UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22124541 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK061823 Date21 Jul 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-E22124541 registered 15 Apr 2026 Active
  • FDA 510(k) K061823 decided 21 Jul 2006 Active· +1 more in the status table
  • FDA GUDID UDI-DI E22124541 listed 31 Aug 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K994056
  2. Cleared FDA 510(k) K061823
  3. Listed FDA GUDID E22124541
  4. Registered EUDAMED B-E22124541

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Admira
Generic name
Dental composite resin
Model / Ref / Catalog
2454, caps
Primary DI / UDI-DI
E22124541
Basic UDI-DI
B-E22124541
510(k) Number
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 · 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

Cleared under the same submission (K061823)

and 8 more cleared under K061823

Cleared under the same submission (K994056)

and 8 more cleared under K994056

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)