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510(k) Data Aggregation

    K Number
    K083324
    Device Name
    LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
    Manufacturer
    ZEST ANCHORS, INC.
    Date Cleared
    2009-02-25

    (105 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K132125,K220612
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

    The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed clinical study report addressing performance metrics.

    Therefore, I cannot provide the requested information based on the given text.

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