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OKTAGON Implant System

by Hager& Meisinger GmbH EUDAMED510(k)

Active European Union and United States

510(k) K180360

Overview

The OKTAGON Implant System is a dental implant designed for oral and maxillofacial reconstruction, classified as a Dental Implant under nomenclature standards. It provides bone-level and tissue-level options, constructed from Titanium Grade 4 for biocompatibility and stability in osseointegration. The system is engineered to support single-tooth and multi-tooth restorations with tapered designs for enhanced primary stability.

The OKTAGON Implant System is supplied sterile and intended for single-use in surgical procedures. It is available in bone-level and tissue-level configurations, with tapered designs, and must be implanted by trained dental professionals in controlled clinical settings. Regulatory authorisations include FDA 510(k) clearance under the Traditional pathway (K180360) and compliance with the Medical Device Regulation (MDR). Storage requires adherence to manufacturer guidelines for sterility and handling.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK180360 Date10 May 2018ClearedStatusActive
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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

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 dental restorations can the OKTAGON Implant System support, and why is the tapered design important for stability?

    The OKTAGON Implant System is designed to support both single-tooth and multi-tooth restorations. The tapered design enhances primary stability by providing a wider base at the bone interface, which improves osseointegration and load distribution during the healing process. This feature is particularly useful in challenging clinical scenarios where immediate stability is critical.

  • Is the OKTAGON Implant System reusable, or is it intended for single-use only? How does this affect its sterility?

    The OKTAGON Implant System is explicitly intended for single-use only in surgical procedures. This design choice ensures sterility is maintained throughout its intended use, as it is supplied sterile and must not be reused. Single-use also reduces the risk of cross-contamination and maintains compliance with infection control protocols in clinical settings.

  • What materials is the OKTAGON Implant System made from, and why is this important for dental implants?

    The OKTAGON Implant System is constructed from Titanium Grade 4, a material chosen for its exceptional biocompatibility and mechanical stability. Titanium Grade 4 is well-tolerated by the body, minimizes allergic reactions, and provides the necessary strength for osseointegration—where bone grows directly onto the implant surface—ensuring long-term durability and patient safety.

  • Are there different configurations for the OKTAGON Implant System, and how do bone-level and tissue-level options differ?

    Yes, the OKTAGON Implant System offers bone-level and tissue-level configurations, catering to different clinical needs. Bone-level implants are fully submerged beneath the gum tissue, ideal for cases requiring greater bone integration. Tissue-level implants, on the other hand, expose part of the implant above the gumline, which can simplify prosthetic placement and maintenance. The choice depends on the patient’s anatomy and the intended restoration.

  • What storage guidelines should be followed to maintain the sterility of the OKTAGON Implant System?

    The OKTAGON Implant System must be stored according to the manufacturer’s guidelines to preserve sterility. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until immediately before use, protected from moisture, contamination, and physical damage. Exposure to these factors could compromise sterility, so adherence to the provided storage instructions is essential for clinical safety.