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OneArch Scan Body KIT

by OSSTEM IMPLANT Co., Ltd. 2 variants

Ref KSNSBETH

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800342290136 UDI-DI Date2 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000406CLASSIBUSANHY Basic UDI-DI 08800342290136UDI-DIDate11 Feb 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Name
Impression Tool System
Model / Reference
KSNSBETH EUDAMED
HOASBK GUDID
Primary DI / UDI-DI
08800342290136
Basic UDI-DI
88000406CLASSIBUSANHY
FDA Product Code
NYE
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
KSNSBETH
GUDID
HOASBK
SterileEUDAMED
Yes
GUDID
No

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

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Single Use: 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No