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510(k) Data Aggregation

    K Number
    K132825
    Device Name
    RETROMTA-ORTHOMTA II
    Manufacturer
    Date Cleared
    2014-04-10

    (213 days)

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

    BIOMTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RetroMTA-OrthoMTA II is indicated for use as: - Orthograde root canal filling material - Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal and external resorption. - Repair of root canals as an apical plug during apexification - Root end filling - Pulp capping
    Device Description
    The major compositions of the RetroMTA-OrthoMTA II are dicalcium silicate, tricalcium silicate and tricalcium aluminate, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and is used in a putty form which gradually hardens in the oral environment. RetroMTA-OrthoMTA II is ideal for orthograde root canal filling. It is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
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