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510(k) Data Aggregation

    K Number
    K111782
    Device Name
    BEAUTISEALANT
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2011-09-16

    (84 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BeautiSealant is resin material intended for sealing of pits and fissures, which is polymerized by visible light energy (external energy). 'Primer' modifies enamel surface with its adhesive monomer to bond 'Paste' to enamel.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding a 510(k) premarket notification for a dental product called "BeautiSealant." It discusses regulatory compliance and substantial equivalence to predicate devices, but it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

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