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Fibres 680284

by Candulor AG

Part of a family of 38 devices: see the family page

Ref 680284

Fibres 680284 is a device classified as Class IIa in the EU and Class II in the US made by Candulor AG, registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 763081342APROS001VC) and listed in FDA GUDID since 14 Nov 2022 (UDI-DI 07630813439839), active as of 23 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number763081342APROS001VC Basic UDI-DI 07630813439839UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630813439839 UDI-DI Date14 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 763081342APROS001VC registered 7 Aug 2026 Active
  • FDA GUDID UDI-DI 07630813439839 listed 14 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630813439839
  2. Registered EUDAMED 763081342APROS001VC

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Fibres 0,5g EUDAMED
Fibres GUDID
Generic name
Dental appliance fabrication material, resin
Device name
Aesthetic Blue, Aesthetic Red
Model / Ref / Catalog
680284
Primary DI / UDI-DI
07630813439839
Basic UDI-DI
763081342APROS001VC
FDA product code
EBI
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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 appliance fabrication material, resin

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Candulor AG

See all devices from Candulor AG →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)