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510(k) Data Aggregation

    K Number
    K980577
    Device Name
    PRINCESS SYRINGE
    Manufacturer
    SODEXCO
    Date Cleared
    1998-05-08

    (80 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. It is intended to deliver air and water spray during dental procedures.

    Device Description

    The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. This device has only one as of the orgal causiv during dental procedures.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Princess Syringe". This document primarily discusses the regulatory approval of the device and its substantial equivalence to previously marketed devices.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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