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510(k) Data Aggregation

    K Number
    K962753
    Device Name
    KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
    Manufacturer
    BIOMEDICAL IMPLANT TECHNOLOGY, INC.
    Date Cleared
    1997-05-19

    (308 days)

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

    The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.

    Device Description

    Kwan hexagonal Abutment Implant System (HAIS)

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental implant system. It acknowledges the device's substantial equivalence to previously marketed devices and outlines regulatory information. However, it does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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