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    K Number
    K014059
    Device Name
    PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2002-02-27

    (79 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE

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

    PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel to adhere orthodontic brackets to tooth surfaces.

    Device Description

    PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain any information about acceptance criteria or a study proving device performance.

    Therefore, I cannot fulfill your request for the specific details you've asked for. The document is strictly a regulatory clearance and does not include scientific study results or performance metrics.

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