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510(k) Data Aggregation

    K Number
    K243078
    Device Name
    HexaPLUS S OneDrill Implant System
    Manufacturer
    Osseofuse International Inc.
    Date Cleared
    2025-10-10

    (375 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K131748,K110577,K181157
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.

    Device Description

    The HexaPLUS S OneDrill Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the indications for use, the technology used, the material compositions and performance characteristics. The surface of the implants are treated by SLA method. Implants with 4.50mm and 5.25mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, 14.5, and 16 mm. Implants with 6.5mm and 7.5mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, and 14.5.

    The system includes the following components.

    Fixtures

    • Size: 4.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
    • 5.25mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
    • 6.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5
    • 7.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5

    Abutments

    • Healing Abutment
    • One-Step Abutment
    • Final Cement Abutment
    • Straight Abutment
    • Angled Abutment
    • Temporary Abutment
    • Ball Abutment

    Cover Screw

    • Size: 3.45mm (Dia.) x 4.9

    Abutment Screw

    • Size: 2.30mm (Dia.) x 8.25

    Multi Angle Abutment Screw

    • Size: 2.30mm (Dia.) x 8.20
    AI/ML Overview

    N/A

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