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510(k) Data Aggregation

    K Number
    K990252
    Device Name
    SOLO PLUS ORTHO
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1999-02-25

    (29 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Solo Plus Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

    Device Description

    The device is a universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Plus Ortho may be light cured, using Solo Plus Ortho Primer A, or chemical cured using Solo Plus Ortho Primer A and Solo Plus Ortho Primer B.

    AI/ML Overview

    I am sorry, but the provided text Kaa052 does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental product called "Solo Plus Ortho," seeking substantial equivalence to existing devices. It focuses on device description, intended use, and regulatory classification, not on performance studies with specific statistical metrics.

    Therefore, I cannot extract the requested information, including:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • Results of any MRMC comparative effectiveness study.
    • Results of any standalone performance study.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.
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