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    K Number
    K131212
    Device Name
    PREMIER CERAMIC PRIMER
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2013-08-26

    (119 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PREMIER CERAMIC PRIMER

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

    Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains regulatory correspondence from the FDA regarding a 510(k) premarket notification for the "Premier Ceramic Primer." It discusses the device's classification, general controls, and indications for use.

    However, the document does not contain any information about acceptance criteria, study design, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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