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510(k) Data Aggregation

    K Number
    K151047
    Device Name
    MTA Repair HP
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
    Date Cleared
    2016-08-31

    (499 days)

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

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    * Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions; * Via canal treatment of root perforation due to internal resorption; * Surgical treatment of root perforation due to internal resorption; * Periapical surgery with reverse filling; * Pulp capping; * Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion) * Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp) * Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
    Device Description
    MTA REPAIR HP is an endodontic bioceramic reparative cement with high plasticity, composed of mineral oxides in the form of fine hydrophilic particles. It is indicated for cases of root perforation (canal and furcation), iatrogenic or by caries, root perforation by internal resorption, retrofilling, direct pulp capping, pulpotomy, apexigenesis, and apexification. The plasticizer Polyvinylpyrrolidone is added in the subject device to improve the plasticity of the mixture powder/liquid, with plasticity being understood as the quality of being easily shaped or molded. Thus, the new formulation of the subject device improves handling and insertion into the dental cavity since the pasted after mixing becomes a molding putty type consistency. The radiopacifier CaWO4 is also added in the subject device to prevent discoloration of the tooth, since CaWO4 does not reduce when exposed to sunlight, unlike Bi2O3 found in the predicate device. Overall properties noted for the subject device include the following: . Setting time: MTA Repair HP solidifies upon being maintained in a wet environment after spatulation. The start setting time is approximately 15 minutes. . Radiopacity: Similar to gutta-percha and more radiopaque than dentin and bone. . Absence of dental discoloring due to the radiopacifier CaWO4 used.
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    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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    K Number
    K123823
    Device Name
    INTERLIG
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
    Date Cleared
    2013-05-31

    (170 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interlig is indicated for: - Splinting periodontal involved and mobile teeth to prevent movement - To reinforce full denture and partial denture repairs - As a matrix between abutment teeth for receiving a temporary replacement tooth - As an aid in the reinforcement of temporary crowns and bridge work - As a space maintainer for orthodontic involved teeth
    Device Description
    Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.
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    K Number
    K112046
    Device Name
    MTA ANGELUS
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
    Date Cleared
    2012-01-06

    (172 days)

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

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions - Via canal treatment of root perforation due to internal resorption - Surgical treatment of root perforation due to internal resorption - Periapical surgery with reverse filling - Pulp capping - Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue) - Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp). - Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
    Device Description
    MTA Angelus is a mineral trioxide aggregate cement used for root repair during endodontic treatment, combining the powder and liquid produces a colloidal gel that solidifies to form a barrier.
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    K Number
    K082180
    Device Name
    PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
    Manufacturer
    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
    Date Cleared
    2008-12-17

    (138 days)

    Product Code
    EBI, CLA
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perma Fiber / Perma Mesh is indicated for use as reinforcement for: - · Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances - · Temporary and/or permanent plastic/composite crowns and bridges - · Custom splinting for immobilization of teeth
    Device Description
    Perma Fiber / Perma Mesh glass fiber reinforcement material
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