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Abutment

by Biotec S.R.L. EUDAMED

Active European Union

Ref 260KR4A0Model ABUTMENT, LOCATOR ABUTMENT, CONNECTOR ABUTMENT, RING ABUTMENT, BT4 ABUTMENT, TEMPORARY ABUTMENT, AESTHETIC ABUTMENT, TRANSFER ABUTMENT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D748ABUTMENTSLB Basic UDI-DIDate31 Jan 2023RegisteredStatusActive

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  • Withdrawn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
Abutment
Model / Reference
ABUTMENT, LOCATOR ABUTMENT, CONNECTOR ABUTMENT, RING ABUTMENT, BT4 ABUTMENT, TEMPORARY ABUTMENT, AESTHETIC ABUTMENT, TRANSFER ABUTMENT, 260KR4A0
Primary DI / UDI-DI
+D748260KR4A00D
Basic UDI-DI
++D748ABUTMENTSLB
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

  • 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