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Castable Plastic Abutment

by Biotec S.R.L. EUDAMED

Active European Union

Ref 205EN1R1Model CASTABLE PLASTIC ABUTMENT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number007-00-06-MDR Date27 Apr 2026IssuedStatusActive expires 20 Dec 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 007-00-06-MDR Supplemented

    Quality management system EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    27 Apr 2026
    Expires
    20 Dec 2027
    Reason
    Add device or group
  • 008-00-04-MDR Supplemented

    Technical documentation EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    5 Mar 2026
    Expires
    20 Dec 2027
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Castable Plastic Abutment
Model / Reference
CASTABLE PLASTIC ABUTMENT, 205EN1R1
Primary DI / UDI-DI
+D748205EN1R10H
Basic UDI-DI
++D748CASPLASABUTJ
EMDN Code
Q010299 Prosthetic dentistry devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026774

Other devices from Biotec S.R.L.

See all devices from Biotec S.R.L. →

Properties

Show properties
  • Implantable
Other properties (13)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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