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KEROX ZIRCOSTAR Pre-sintered zirconium-dioxide blank Ultra High TranslucentU3 unique shade 25 mm height 98 mm diameter flanged S type

by KEROX Ipari és Kereskedelmi Korlátolt Felelősségű Társaság

Ref CU3U9825AP

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5996612CUS00002F Basic UDI-DI 05996612010740UDI-DIDate27 May 2026RegisteredStatusWithdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Ultra Hight Translucent - S Raw Material
Model / Reference
CU3U9825AP
Primary DI / UDI-DI
05996612010740
Basic UDI-DI
5996612CUS00002F
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000031741

Properties

Other properties (13)

  • 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