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510(k) Data Aggregation

    K Number
    K122908

    Validate with FDA (Live)

    Device Name
    PRG BARRIER COAT
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2013-04-26

    (217 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PRG BARRIER COAT, is a light-cured two-component mixing type, tooth surface coating material as well as desensitizer to relieve dentin hypersensitivity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a clearance letter and indications for use, not a detailed study report. Therefore, I cannot generate the requested table and information.

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