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TS Stud Abutment

by OSSTEM IMPLANT Co., Ltd. 24 variants

Ref GSSA3560, TSST3520R, TSSA3520, TSST3550M, TSST3540R, TSST3540M, TSST3560M, TSSAM3540, TSSA3540, TSSA3560, TSST3530M, TSST3510M, TSST3520M

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406ABUTMENTRZ Basic UDI-DI Date26 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800000970622 UDI-DI Date21 Sep 2017ListedStatusListed GUDID: in commercial distribution

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

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1274-2025 FDA Class II initiated 27 Jan 2025
    • Ongoing Z-1276-2025 FDA Class II initiated 27 Jan 2025

    Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

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  • Withdrawn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

Trade Name
TS Stud Abutment EUDAMED
OSSTEM Implant System - Abutment GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Dental Abutment System
Dental Abutment System(STERILE)
Model / Reference
GSSA3560, TSST3520R, TSSA3520, TSST3550M, TSST3540R, TSST3540M, TSST3560M, TSSAM3540, TSSA3540, TSSA3560, TSST3530M, TSST3510M, TSST3520M
Primary DI / UDI-DI
08800000970622, 08809917085023, 08809917084880, 08809917085078, 08809917085061, 08809917085054, 08809917085092, 08809917084965, 08809917084903, 08809917084927, 08809917085030, 08809917084996, 08809917085016
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
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
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
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 NoEUDAMEDGUDIDYesEUDAMED
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • 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
  • Expiration Date: No