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510(k) Data Aggregation

    K Number
    K992838
    Device Name
    ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
    Date Cleared
    1999-11-15

    (84 days)

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

    BIOMAT SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns. to seal dentinal tubules to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth to promote bonds between incremental layers of composite resins when building a composite restoration to bond composite resins repairs to ceramics and metals
    Device Description
    Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.
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