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Intraoral Scanbody Screw

by ARUM DENTISTRY Co., Ltd. 317 variants

Ref OSSH132

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

Introducing the Intraoral Scanbody Screw, a revolutionary medical device designed to enhance dental implant surgeries with precise and accurate scans. This innovative tool combines advanced technology with user-friendly design, making it an essential addition to any medical professional's toolkit.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000557ISBXH Basic UDI-DI 08809950311370UDI-DIDate2 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
OSSH132
Primary DI / UDI-DI
08809950311370
Basic UDI-DI
88000557ISBXH
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009313
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from ARUM DENTISTRY Co., Ltd.

See all devices from ARUM DENTISTRY Co., Ltd. →

Properties

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