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510(k) Data Aggregation

    K Number
    K240365
    Device Name
    Bioceramic Root Repair Material (C-Root BP)
    Manufacturer
    Beijing C-Root Dental Medical Devices Co., Ltd.
    Date Cleared
    2024-05-10

    (94 days)

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

    Beijing C-Root Dental Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping
    Device Description
    C-Root BP Bioceramic Root Repair Material (C-Root BP) is a convenient ready-to-use premixed bioceramic paste developed for permanent root canal repair and surgical applications. C-Root BP is an insoluble, radiopaque and aluminum-free material based on a strontium silicate composition, which requires the presence of water to set and harden. C-Root BP does not shrink during setting and demonstrates excellent physical properties. C-Root BP is packaged in a Preloaded syringe.
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    K Number
    K212983
    Device Name
    Injectable Root Canal Bioceramic Sealer
    Manufacturer
    Beijing C-Root Dental Medical Devices Co., LTD.
    Date Cleared
    2021-12-08

    (82 days)

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

    Beijing C-Root Dental Medical Devices Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    * Permanent obturation of the root canal following vital pulpextirpation. * Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
    Device Description
    C-Root SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. C-Root SP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. C-Root SP does not shrink during setting and demonstrates excellent physical properties. C-Root SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. C-Root SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. C-Root SP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in2g; 1g; 0.5g. The only difference between the types are the net weight.
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