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510(k) Data Aggregation

    K Number
    K102753
    Device Name
    TURBO TEMP 3
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2011-02-04

    (134 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TURBO TEMP 3

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

    Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

    Device Description

    Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter regarding K102753 does not contain information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any information about AI or MRMC studies.

    The document is a 510(k) clearance letter for a temporary crown and bridge material called "Turbo Temp 3," indicating it has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulation name, regulatory class, and product code, along with general regulatory information and contact details.

    Therefore, I cannot provide the requested table and study details based on the given input.

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