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Candulor Preference 578470

by Candulor AG

Ref 578470

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number763081342APROS002VE Basic UDI-DI 07630813499826UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630813499826 UDI-DI Date16 Nov 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Preference 6er O420+ B4 EUDAMED
Candulor Preference GUDID
Generic Name
Resin artificial teeth
Device Name
Physioset TCR, Bonartic TCR, PhysioSelect TCR, BonSelect TCR, Preference, Bonartic II NFC plus, PhysioStar NFC plus, Condyloform II NFC plus
Model / Ref / Catalog
578470
Primary DI / UDI-DI
07630813499826
Basic UDI-DI
763081342APROS002VE
FDA Product Code
ELM
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Resin artificial teeth
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3590
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

Related devices

Category: Resin artificial teeth

Other devices from Candulor AG

See all devices from Candulor AG →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No