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510(k) Data Aggregation

    K Number
    K231259
    Device Name
    iRoot SP Plus
    Date Cleared
    2023-05-31

    (30 days)

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

    Innovative BioCeramix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Permanent obturation of the root canal following vital pulp-extirpation - Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
    Device Description
    iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.
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