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Zirtooth F Z-95-F(A3.5, 12T)

by Hass Corp.

Ref Z-95-F(A3.5,12T), M-95-F(A3.5)(12T)Model Zirtooth

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD Number88000571TD701F2 Basic UDI-DI 08800057100881UDI-DIDate1 Dec 2025RegisteredStatusActive
European UnionCE/MDR Number88000571TD701F2 Basic UDI-DI 08800057100881UDI-DIDate1 Dec 2025RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Zirtooth F Z-95-F(A3.5,12T)
Zirtooth F M-95-F(A3.5)(12T)
Device Name
Zirtooth
Model / Reference
Z-95-F(A3.5, 12T), Zirtooth, M-95-F(A3.5)(12T)
Primary DI / UDI-DI
08800057100881
Basic UDI-DI
88000571TD701F2, B-08800057100881
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011621
Authorised representative
KTR Europe GmbH DE-AR-000005685

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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