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KS Bite Index

by OSSTEM IMPLANT Co., Ltd. 12 variants

Ref KSBI4508S

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 25 Oct 2026. What this means

Overview

The KS Bite Index is a medical device designed for impression take-out procedures in dentistry. It features a unique bite indicator system that allows for accurate and precise impressions, reducing the risk of misinterpretation or loss of data.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000406CLASSIBUSANHY Basic UDI-DI 08800209359204UDI-DIDate11 Feb 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  • Withdrawn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

Device Name
Impression Tool System
Model / Reference
KSBI4508S
Primary DI / UDI-DI
08800209359204
Basic UDI-DI
88000406CLASSIBUSANHY
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000020006
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant 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