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510(k) Data Aggregation

    K Number
    K073209
    Device Name
    MAXCEM 2
    Manufacturer
    KERR CORPORATION
    Date Cleared
    2008-01-29

    (76 days)

    Product Code
    MZW, EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    MZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants. * Adhesive application on the prep is required for veneer cementation using Maxcem 2.
    Device Description
    Maxcem 2 is a self-etch, self-adhesive resin cement offered in a paste/paste formulation indicated for indirect cementation of ceramic, resin and metal restorations including veneers. This product contains 69% filler by weight and is radiopaque. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration or tooth prep.
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    K Number
    K991923
    Device Name
    SOOTHE-N-SEAL CANKER SORE RELIEF
    Manufacturer
    CLOSURE MEDICAL CORP.
    Date Cleared
    1999-09-02

    (87 days)

    Product Code
    MZW
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    MZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.
    Device Description
    SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application. SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life.
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