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510(k) Data Aggregation

    K Number
    K092035

    Validate with FDA (Live)

    Device Name
    BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
    Manufacturer
    BICON, LLC
    Date Cleared
    2009-10-15

    (101 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K103810,K112279,K122198,K130572,K131097,K140347,K141159,K170398,K211409,K213599
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental implant device. It primarily focuses on the regulatory approval process and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot extract the requested information from this document.

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