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510(k) Data Aggregation

    K Number
    K090457
    Device Name
    ORALUBE
    Manufacturer
    PULPDENT CORPORATION
    Date Cleared
    2009-05-21

    (87 days)

    Product Code
    ONK
    Regulation Number
    880.6375
    Why did this record match?
    Product Code :

    ONK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations: - Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material; - Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive; - Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it. - Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.
    Device Description
    Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.
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