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510(k) Data Aggregation

    K Number
    K140247
    Device Name
    MTA FILLAPEX
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
    Date Cleared
    2014-04-25

    (85 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
    Device Description
    MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.
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    K Number
    K132923
    Device Name
    FUSION SINGLE LINK
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
    Date Cleared
    2014-01-03

    (107 days)

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

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
    Device Description
    The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.
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