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Axiom Reg

by Anthogyr Sas France EUDAMED510(k)

510(k) K131066 Product code DZE

Overview

The Axiom REG Implant is an Endosseous Dental Implant (Product Code: DZE), designed for osseointegrated fixation within alveolar bone to support dental prosthetics. It features a Bone Level design, providing primary stability in both soft and dense bone types, and is intended for use in dental restoration procedures requiring reliable anchorage.

This implant is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA 510(k) clearance (K131066) and MDR, with regulatory submissions filed through the Dental (DE) Advisory Committee. Storage and handling must comply with sterile instrument protocols, and its dimensions are standardized for compatibility with dental implant systems. No MRI safety information is specified.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK131066 Date21 Feb 2014ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of bone can the Axiom REG Implant be used in, and why is this important for dental restoration procedures?

    The Axiom REG Implant is specifically designed for osseointegrated fixation in both soft and dense alveolar bone types, providing primary stability. This versatility is important because it ensures reliable anchorage for dental prosthetics regardless of the bone density encountered during restoration procedures, reducing the risk of implant failure or loosening.

  • Is the Axiom REG Implant intended for reuse, or is it meant to be used only once? How does this affect its handling?

    The Axiom REG Implant is intended for single-use only, as explicitly stated in its specifications. This means it must be handled and stored under sterile instrument protocols to maintain its sterility and prevent contamination, ensuring patient safety during dental restoration procedures.

  • What regulatory pathways were followed for the Axiom REG Implant, and which advisory committee was involved in its review?

    The Axiom REG Implant underwent a traditional 510(k) clearance process in the U.S. and is classified under the Medical Device Regulation (MDR) in Europe. Its review was filed through the Dental (DE) Advisory Committee, which evaluates dental implant submissions to ensure compliance with safety and performance standards before clearance.

  • Are there specific storage requirements for the Axiom REG Implant, and why is this important?

    The Axiom REG Implant must be stored and handled according to sterile instrument protocols due to its sterile packaging. This is critical because maintaining sterility prevents infection risks during dental implant procedures, ensuring the implant remains safe and effective for its intended use in osseointegration.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K131066 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 18 May 2026