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510(k) Data Aggregation

    K Number
    K242913
    Device Name
    Jasmate® Toothpaste
    Manufacturer
    Jasberry Healthcare Private Limited
    Date Cleared
    2024-11-22

    (59 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jasberry Healthcare Private Limited

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

    Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

    Device Description

    Jasmate® toothpaste is a dentist and dental professional prescribed, daily-use, fluoride dentifrice to be used in the prevention and treatment of dental sensitivity through the physical occlusion of dentin tubules.

    Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. Sodium fluoride and hydroxyapatite are active ingredients. When exposed environment, it undergoes a rapid surface reaction to form fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA for a new medical device, Jasmate® Toothpaste. It details the device's characteristics, intended use, and a comparison to a predicate device (BioMinF® Toothpaste) to establish substantial equivalence.

    However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software. The tests mentioned are for a physical product (toothpaste) and evaluate properties like density, pH, viscosity, spreadability, foaming power, relative dentin abrasion, enamel fluoride uptake, enamel solubility reduction, and tubule occlusion (via SEM). These are standard physical and chemical performance tests for a dentifrice, not evaluation of an AI system.

    Therefore, I cannot fulfill the request as it pertains to AI/ML acceptance criteria and studies, because the provided input does not describe such a device or its evaluation. The request's template is designed for AI/ML product submissions, while the document describes a chemical/physical product.

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