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by Zirkonzahn SRL FDA registration: Italy EUDAMED

Ref BSAPxx(x)yy(Lvv)(Kvv) EMDN Q01020604

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D800TiBasesQY Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dental Prosthetic Accessories
Model / Reference
BSAPxx(x)yy(Lvv)(Kvv)
Primary DI / UDI-DI
D800BSAPxx(x)yy(Lvv)(Kvv)0
Basic UDI-DI
++D800TiBasesQY
EMDN Code
Q01020604 Orthodontic dental prostheses
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028795

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Zirkonzahn SRL

See all devices from Zirkonzahn SRL →

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
  • Sutures
Other properties (12)
  • Sterile: 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

Sources (1)

  • EUDAMED 019d12a5-1c8d-40a4-96ba-a58e29ea71c7 61 fields · synced 22 Oct 2026