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Abutment

by D.A.N.D Metal Industries North EUDAMEDGUDID

Active European Union and United States

Ref STSA 04Model STANDARD TITANIUM SHOLDER ABUTMENT 4 MM

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290111510564 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290111510564 UDI-DIDate14 Oct 2025ListedStatusIn 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/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Abutment EUDAMED
Shoulder Abutment IH GUDID
Generic Name
Dental implant system
Device Name
Stsa 04
Model / Ref / Catalog
STANDARD TITANIUM SHOLDER ABUTMENT 4 MM EUDAMED
STSA 04 EUDAMED
4mm GUDID
STSA04 GUDID
Primary DI / UDI-DI
07290111510564
Basic UDI-DI
B-07290111510564
510(k) Number
FDA Product Code
NHA
EMDN Code
P010299 Odontological prostheses - other
GMDN Term
Dental implant system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
Romania
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
STANDARD TITANIUM SHOLDER ABUTMENT 4 MM
STSA 04
GUDID
4mm
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IL-MF-000038021
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental implant suprastructure, permanent, preformed

Other devices from D.A.N.D. Metal Industries North, Ltd.

See all devices from D.A.N.D. Metal Industries North, Ltd. →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Reprocessed
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No
  • Manufacturing Date: No