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Axiom

by anthogyr EUDAMEDGUDID

Active European Union and United States

Ref OPST426-15Model Unitary Sterile Abutment/Base/Coping (Titanium)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number36633940105QR Basic UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663394002035 UDI-DIDate31 Jul 2015ListedStatusIn 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

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Generic Name
Dental implant suprastructure, permanent, preformed
Model / Reference
Unitary Sterile Abutment/Base/Coping (Titanium), OPST426-15
Description
STD. ANGULATED TITANIUM ABUT. Ø4.0 h2,5 15° Providing support for a permanent restoration.
Primary DI / UDI-DI
03663394002035
Basic UDI-DI
36633940105QR
FDA Product Code
NHA
EMDN Code
P010299 Odontological prostheses - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
France
Commercial Distribution
In Commercial Distribution
Size
Outer Diameter — 4.0 Millimeter
Angle — 15 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000602

Related devices

Category: Dental implant suprastructure, permanent, preformed

Other devices from Anthogyr Sas

See all devices from Anthogyr Sas →

Properties

Show properties
  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Serial Number: No