Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K242934
    Device Name
    Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
    Manufacturer
    Longly Biotechnology (Wuhan) Co., Ltd.
    Date Cleared
    2024-12-12

    (78 days)

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

    Longly Biotechnology (Wuhan) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications. - Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping
    Device Description
    i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.
    Ask a Question
    K Number
    K241977
    Device Name
    Injectable Root Canal Bioceramic Sealer (i-MTA SP)
    Manufacturer
    Longly Biotechnology (wuhan) CO., LTD
    Date Cleared
    2024-10-03

    (90 days)

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

    Longly Biotechnology (wuhan) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.
    Device Description
    i-MTA 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. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
    Ask a Question

    Page 1 of 1