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510(k) Data Aggregation

    K Number
    K991489
    Device Name
    ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1999-07-15

    (78 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K991490
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alginate Impression Material I mixed with water is used as a dental impression material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an alginate impression material, which is a dental device. It does not describe any acceptance criteria for an AI device, a study proving it meets those criteria, or any of the other details you've asked for regarding AI performance or ground truth establishment.

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