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510(k) Data Aggregation

    K Number
    K960910
    Device Name
    INDERMIL DENTAL
    Manufacturer
    LOCTITE CORP.
    Date Cleared
    1996-03-28

    (23 days)

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

    LOCTITE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indermil™ Dental is indicated for use as a dental cement for bonding dental materials, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
    Device Description
    Indermil™ Dental is liguid n-butvl 2-cyanoacrylate that cures in the presence of anions. Indermil™ Dental is sterilized by gamma radiation, and provided for use in high density polyethylene dispensers.
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