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5400F505

by bredent GmbH & Co. KG Germany(FDA 510(k) applicant) EUDAMED

Ref 5400F505Model thermoplastic, PA EMDN Q01020601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EBRE2aProsthBreFlexZ6 Basic UDI-DIDate22 Jun 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  • Withdrawn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 25 Oct 2026

Model / Reference
thermoplastic, PA, 5400F505
Primary DI / UDI-DI
+EBRE5400F5050C
Basic UDI-DI
++EBRE2aProsthBreFlexZ6
EMDN Code
Q01020601 Mobile dental prostheses
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008124

Other devices from Bredent GmbH & Co.KG

See all devices from Bredent GmbH & Co.KG →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED +EBRE5400F5050C|++EBRE2APROSTHBREFLEXZ6 61 fields · synced 25 Oct 2026