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Dental Abutment System GSTA7610WH

by OSSTEM IMPLANT Co., Ltd.

Ref GSTA7610WH

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222778↗

+4 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406ABUTMENTRZ Basic UDI-DI 08800000971506UDI-DIDate26 Feb 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222778 Date23 Sep 2023IssuedStatusActive
United StatesGUDID listing GUDID Number08800000971506 UDI-DI Date21 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000406ABUTMENTRZ registered 26 Feb 2026 Active
  • FDA 510(k) K222778 decided 23 Sep 2023 Active· +4 more in the status table
  • FDA GUDID UDI-DI 08800000971506 listed 21 Sep 2017 Listed

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

Timeline

9 dated events

  1. Cleared FDA 510(k) K161604
  2. Cleared FDA 510(k) K161689
  3. Listed FDA GUDID 08800000971506
  4. Cleared FDA 510(k) K182091
  5. Cleared FDA 510(k) K221684
  6. Cleared FDA 510(k) K222778
  7. Recall initiated FDA recalls Z-1274-2025
  8. Recall initiated FDA recalls Z-1276-2025
  9. Registered EUDAMED 88000406ABUTMENTRZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Full name
Dental Abutment System
Trade name
OSSTEM Implant System - Abutment
Generic name
Dental implant suprastructure, permanent, preformed
Model / reference
GSTA7610WH
Primary DI / UDI-DI
08800000971506
Basic UDI-DI
88000406ABUTMENTRZ
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 registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dental Abutment System GSTA7610WH is a Class IIb implantable dental device, classified under nomenclature code P01020101. It serves as a critical component in dental implantology, providing a stable interface between dental implants and prosthetic crowns or bridges to restore masticatory function and aesthetics.

This single-use, non-reusable system is manufactured by OSSTEM Implant Co., Ltd., with production attributed to the Haeundae Plant. It is intended for use in oral and maxillofacial surgery settings, adhering to FDA 510K and MDR regulatory standards. The system includes sutures and is supplied sterile, ensuring compatibility for immediate clinical application.

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)