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510(k) Data Aggregation

    K Number
    K991901
    Device Name
    BIO-97
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    1999-09-07

    (95 days)

    Product Code
    EJT,DAT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indicated usage for this product is as a ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental ceramic alloy. It does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study that proves the device meets such criteria.

    The document states that the device, "BIO-97," is a "ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations." However, it does not provide any performance metrics, study designs, sample sizes, or ground truth details.

    Therefore, I cannot fulfill the request for information about acceptance criteria or a study proving device performance based on the input provided. The document is largely administrative, confirming the device's substantial equivalence to previously marketed devices and outlining regulatory obligations.

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