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Ti Blank Abutment [Abutment + Screw]

by Izenimplant Co., Ltd 48 variants

Ref TBASRH12AS

Active European Union

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800070221594 Basic UDI-DI 08800070221594UDI-DIDate21 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
TBASRH12AS
Primary DI / UDI-DI
08800070221594
Basic UDI-DI
B-08800070221594
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000026205
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Izenimplant Co., Ltd

See all devices from Izenimplant Co., Ltd →

Properties

  • Implantable

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