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510(k) Data Aggregation

    K Number
    K033309
    Device Name
    PREMIER IMPLANT CEMENT, MODEL 3001450
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2004-01-26

    (104 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PREMIER IMPLANT CEMENT, MODEL 3001450

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

    Premier Implant Cement™ is a non-eugenol temporary cement for luting implant-retained crowns.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be an FDA 510(k) clearance letter for a dental cement, not a study report for an AI/ML medical device.

    Therefore, I cannot extract the information requested about acceptance criteria and a study proving device performance in the context of an AI/ML product. The document describes the regulatory clearance of a traditional medical device (dental cement) based on substantial equivalence to a predicate device, as opposed to performance criteria demonstrated through a clinical study for an AI algorithm.

    The questions you've asked are highly specific to the evaluation of AI/ML-based medical devices, which require different types of studies and performance metrics than the 510(k) clearance process outlined for this dental cement.

    To answer your request, I would need a document describing a clinical study or validation report for an AI/ML medical device, not a 510(k) clearance letter for a conventional device.

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