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510(k) Data Aggregation

    K Number
    K050712
    Device Name
    4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
    Manufacturer
    BICON, INC.
    Date Cleared
    2005-04-22

    (36 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT

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

    The 4.5 x 6.0mm and the 6.0 x 6.0mm implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental implant. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on performance metrics of the device itself beyond its stated indications for use.

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