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510(k) Data Aggregation

    K Number
    K992609
    Device Name
    HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-09-22

    (49 days)

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

    HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

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

    Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain information about the acceptance criteria or a study proving device performance on those criteria. The document is a 510(k) premarket notification letter from the FDA to Kay-See Dental Manufacturing Company concerning their Hydro-Cast/Kay-See Dental Silicone Soft Liner II.

    The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that no new clinical studies were required to demonstrate the device's safety and effectiveness compared to a device already on the market prior to May 28, 1976, or one that has been reclassified.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in this document because the device's approval was based on demonstrating substantial equivalence, not on fulfilling specific performance criteria from a new clinical study.

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