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510(k) Data Aggregation

    K Number
    K993556
    Device Name
    LIQUIBAND DENTAL
    Date Cleared
    2000-01-03

    (75 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LiquiBand® Dental n-butyl cyanoacrylate is intended for use as an adhesive when bonding of caps and crowns to teeth is desired.
    Device Description
    The LiquiBand® Dental adhesive formula consists of n-butyl cyanoacrylate monomer containing small amounts of hydroquinone (a free radical inhibitor) and sulfur dioxide (an anionic inhibitor). LiquiBand® Dental, n-butyl cyanoacrylate adhesive, is a clear, colorless, free-flowing liquid packaged in a single use, 0.5 gram high density polyethylene ampoule with an attachable polypropylene applicator tip. It is applied as a liquid monomer to the bonding surface of the cap/crown to be cemented to a tooth. Upon seating the cap/crown and contact with weak bases LiguiBand® Dental polymerizes as to form a strong adhesive bond between the cap/crown and tooth.
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    K Number
    K972081
    Device Name
    SUPERSKIN
    Date Cleared
    1997-12-17

    (197 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices. SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear. Do not apply over broken skin.
    Device Description
    SuperSkin® is a topically-applied skin protectant for use on unbroken skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
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