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510(k) Data Aggregation

    K Number
    K040465
    Device Name
    LATIT FLOW
    Manufacturer
    AB ARDENT
    Date Cleared
    2004-07-20

    (148 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LATIT FLOW

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

    LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

    Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations

    Contra indications:

    The placement of LATIT FLOW is contraindicated

    If a dry working field cannot be established or if the stipulated technique cannot be applied.

    If the patient is known to be allergic to the components of LATIT FLOW.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental filling material named "LATIT FLOW."

    This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a predicate device already on the market, based on its intended use and submitted information. It does not typically include detailed reports of performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

    The document lists the device's indications for use and contraindications, but it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance for a test set.
    • Details about experts or adjudication methods for ground truth.
    • Information about MRMC studies or effect sizes.
    • Standalone algorithm performance.
    • Ground truth types.
    • Training set sample sizes or how their ground truth was established.

    Therefore, I cannot fulfill your request with the given input.

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