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    K Number
    K041938
    Device Name
    MAXIMUS OS (OVERDENTURE SYSTEM)
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Date Cleared
    2004-07-22

    (3 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K032351,K023067
    Why did this record match?
    Device Name :

    MAXIMUS OS (OVERDENTURE SYSTEM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioHorizons Maximus OS Implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

    Device Description

    The BioHorizons Maximus OS overdenture system dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm and tissue collar heights of 2mm and 4mm, available with each length. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

    The device is further processed by roughening the surface with tricalcium phosphate blast media to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 106, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

    The Maximus OS dental implant is a comprehensive system containing implants and surgical components, with the implants configured specifically for use in denture stabilization: reference the Intended Use section following.

    All BioHorizons implants referenced in this submission are 3.0mm in diameter with D3 thread form and surface treatment using tricalcium phosphate blast media.

    AI/ML Overview

    This 510(k) premarket notification for the BioHorizons Maximus™ OS (Overdenture System) Implant does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The document is a submission to the FDA seeking clearance for a new medical device based on its substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and its technological characteristics, emphasizing its similarities to existing products.

    Therefore, I cannot provide the requested information. The 510(k) submission process relies on demonstrating equivalence rather than presenting novel performance study data against specific acceptance criteria.

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