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510(k) Data Aggregation

    K Number
    K990448
    Device Name
    THE.R.MO.FREE
    Manufacturer
    DENTAMAX, INC.
    Date Cleared
    1999-03-23

    (39 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE.R.MO.FREE

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

    Fabrication or repair of bases for partial or full dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "THE.R.MO.FREE" used for the "Fabrication or repair of bases for partial or full dentures."

    However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter based on substantial equivalence to a predicate device, not a performance study report.

    Therefore, I cannot provide the requested information from this document. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in clinical study reports or comprehensive device testing summaries, which are not part of this 510(k) clearance letter.

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