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510(k) Data Aggregation

    K Number
    K032448
    Device Name
    ALTATEC CERAMIC ABUTMENT
    Manufacturer
    ALTATEC BIOTECHNOLOGIES
    Date Cleared
    2003-08-22

    (14 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K100152
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

    The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.

    Device Description

    ALTATEC Camlog Implant System and Abutments

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the ALTATEC Camlog Implant System and Abutments. It declares substantial equivalence to a predicate device, but does not contain information about acceptance criteria or a study proving the device meets them.

    Therefore, I cannot extract the requested information from the provided document.

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