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Self-Tapping Implant Internal Torque 3.75 X 8.5 Mm - Ext. Hex

by A. S. Technology Componentes Especiais LTDA. Brazil EUDAMED

Ref IT 385Model HE IT IMPLANT EMDN P01020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07908424007694 Basic UDI-DIDate16 Jun 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Dental Implants
Model / Reference
HE IT IMPLANT, IT 385
Primary DI / UDI-DI
07908424007694
Basic UDI-DI
B-07908424007694
EMDN Code
P01020101 Dental implants
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
BR-MF-000011065
Authorised representative
Eurofix - Implantes e Componentes Dentários, Lda. PT-AR-000005254

Other devices from A. S. Technology Componentes Especiais LTDA.

See all devices from A. S. Technology Componentes Especiais LTDA. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 07908424007694|B-07908424007694 61 fields · synced 25 Oct 2026