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510(k) Data Aggregation

    K Number
    K230797
    Device Name
    SmartMTA Capsule
    Date Cleared
    2023-03-24

    (2 days)

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

    Sprig Oral Health Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartMTA Capsule 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 - Pulpotomy/Partial Pulpotomy
    Device Description
    The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment. SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule 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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