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510(k) Data Aggregation

    K Number
    K150933
    Device Name
    iBond Universal & iBond Ceramic Primer
    Date Cleared
    2015-07-07

    (92 days)

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

    Heraeus Kulzer LLC, Mitsui Chemicals Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or selfcuring core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations. The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.
    Device Description
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