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510(k) Data Aggregation

    K Number
    K180802
    Device Name
    Meta P&Bond
    Date Cleared
    2018-08-29

    (154 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    META BIOMED, CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - · A dental adhesive formulated to adhesively bond to hard tissues of the oral cavity, enamel and dentin - · Dentin-enamel primer/bonding agent for direct composite restorations - · Indirect composite restorative luting system - · Porcelain veneer luting system - · Bonding composite to composite - · Bonding composite to metal/amalgam - · Adhesive amalgam restorations
    Device Description
    Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements. It is useful as a primer for use with other methacrylate cements. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite, and composite to metal/amalgam. Meta P&Bond is packaged with Microbrush accessories.
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