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TS Multi Angled Abutment

by OSSTEM IMPLANT Co., Ltd. EUDAMEDGUDID

Active European Union and United States

Ref GS30MAM4850WH, TS17MAS4820WH, TS17MUA482MWH, TS17MUA484MWH, TS30MUA484MWH, TS30MAM4850WH, TS17MUA482RWH, TS17MAS4830WH, TS30MUA484RWH, TS17MUA483MWH, TS30MAS4830WH, TS30MAM4840WH, TS17MAM4840WH, TS30MAM4830WH

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406ABUTMENTRZ Basic UDI-DIDate26 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800000992426 UDI-DIDate11 May 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
TS Multi Angled Abutment EUDAMED
Osstem Abutment System GUDID
TS Abutment System GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Dental Abutment System
Dental Abutment System(STERILE)
Model / Reference
GS30MAM4850WH, TS17MAS4820WH, TS17MUA482MWH, TS17MUA484MWH, TS30MUA484MWH, TS30MAM4850WH, TS17MUA482RWH, TS17MAS4830WH, TS30MUA484RWH, TS17MUA483MWH, TS30MAS4830WH, TS30MAM4840WH, TS17MAM4840WH, TS30MAM4830WH
Primary DI / UDI-DI
08800000992426, 08809917090058, 08800342289093, 08800342289130, 08800342289185, 08809917108289, 08800342289109, 08809917090065, 08800342289192, 08800342289116, 08809917090102, 08809917090096, 08809917090041, 08809917090089
Basic UDI-DI
88000406ABUTMENTRZ, 88000406CSHAKX
510(k) Number
FDA Product Code
NHA
EMDN Code
P01020101 Dental implants
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
Czechia
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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 NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date

Other properties (16)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No