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KEROX ZIRCOSTAR Pre-sintered zirconium-dioxide blank 3 Dimensions MultilayerB2 VITA shade 16mm height 98mm diameter flanged S type

by KEROX Ipari és Kereskedelmi Korlátolt Felelősségű Társaság 2 variants

Ref CB2Z9816AP

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn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Withdrawn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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5996612C3S0000LX Basic UDI-DI 05996612002479UDI-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  • Withdrawn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European Union — CE/MDR Withdrawn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
3 Dimensions Multilayer - S Raw Material
Model / Reference
CB2Z9816AP
Primary DI / UDI-DI
05996612002479
Basic UDI-DI
5996612C3S0000LX
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