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Axiom OPTS161

by Etablissements Anthogyr

Ref OPTS161Model Unitary Screw (Titanium)

Axiom OPTS161 is a device classified as Class IIb in the EU and Class II in the US made by Etablissements Anthogyr, registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 36633940109QZ) and listed in FDA GUDID since 31 Jul 2015 (UDI-DI 03663394002493), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number36633940109QZ Basic UDI-DI 03663394002493UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663394002493 UDI-DI Date31 Jul 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 36633940109QZ registered 20 Apr 2026 Active
  • FDA GUDID UDI-DI 03663394002493 listed 31 Jul 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03663394002493
  2. Registered EUDAMED 36633940109QZ

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  • Withdrawn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
Axiom
Generic name
Dental implant suprastructure, permanent, preformed
Model / reference
OPTS161, Unitary Screw (Titanium)
Description
PROSTHETIC FIXING SCREW Screwing temporary abutment or standard abutment on the master model in the laboratory,
Primary DI / UDI-DI
03663394002493
Basic UDI-DI
36633940109QZ
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
EU registration type
Standard device
EU market of registration
France
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.

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under ODONTOLOGICAL PROSTHESES - OTHER.

Other devices from Etablissements Anthogyr

See all devices from Etablissements Anthogyr →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)