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510(k) Data Aggregation

    K Number
    K020502
    Device Name
    SOLO ORTHO 3
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2002-05-01

    (76 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 Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

    Device Description

    The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 3 can be used with either chemical or light cured adhesive systems.

    AI/ML Overview

    Given the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in the prompt for the Solo Ortho 3 device.

    The document is a 510(k) summary for the Solo Ortho 3 orthodontic bonding primer, stating its substantial equivalence to a predicate device (Solo Ortho 2). It provides administrative details, device description, intended use, and the FDA's clearance letter.

    Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, or other performance-related information based on the provided input.

    The document does not describe:

    • Any performance studies (clinical or benchtop) to demonstrate the device meets specific acceptance criteria.
    • Quantitative performance metrics or benchmarks.
    • Data provenance, sample sizes, or details about ground truth establishment.
    • Any multi-reader multi-case (MRMC) or standalone performance studies.
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