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    K Number
    K061997
    Device Name
    PREMIER SELF-ETCHING ENAMEL SEALANT
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-10-04

    (82 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PREMIER SELF-ETCHING ENAMEL SEALANT

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

    Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a dental sealant and does not include details about device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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