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    K Number
    K250710
    Device Name
    Injectable Root Canal Bioceramic Sealer (nRoot SP)
    Manufacturer
    Enpuno Co., Ltd
    Date Cleared
    2025-06-11

    (93 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    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. Injectable Root Canal Bioceramic Sealer (nRoot SP) is suitable for use in the single cone and lateral condensation technique.
    Device Description
    Injectable Root Canal Bioceramic Sealer (nRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. nRoot SP is an insoluble, radiopaque on a calcium silicate composition, which requires the presence of water to set and harden. nRoot SP does not shrink during setting and demonstrates excellent physical properties. nRoot SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. nRoot SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. Injectable Root Canal Bioceramic Sealer (nRoot SP) is available in five preloaded syringe mode that provide different in specification in 5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight. The performance of the Injectable Root Canal Bioceramic Sealer (nRoot SP) conforms to ISO 6876:2012 Dentistry - Root canal sealing materials.
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    K Number
    K243353
    Device Name
    One-Fil Putty
    Manufacturer
    MEDICLUS CO., LTD.
    Date Cleared
    2025-03-14

    (136 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Furcation or root perforation treatment via canal - 2. Furcation or root perforation treatment via surgical - 3. Internal reabsorption treatment via canal or surgical - 4. External reabsorption treatment - 5. Retrofilling in parendodontic surgery - 6. Direct and indirect pulp capping - 7. Apexification - 8. Apexogenesis and Pulpotomy
    Device Description
    One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.
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    K Number
    K243546
    Device Name
    AH Plus Endodontic Sealer
    Manufacturer
    Dentsply Sirona Inc.
    Date Cleared
    2025-02-13

    (90 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent obturation of root canals of the secondary dentition in combination with root canal points.
    Device Description
    AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.
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    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
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    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.
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    K Number
    K242702
    Device Name
    VioSeal
    Manufacturer
    SPIDENT CO., LTD.
    Date Cleared
    2024-11-07

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent obturation of root canals of the permanent teeth in combination with root canal points
    Device Description
    VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.
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    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
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    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.
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    K Number
    K241457
    Device Name
    Vista BC Putty
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2024-08-28

    (97 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    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
    Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties. 1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
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    K Number
    K240304
    Device Name
    Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
    Manufacturer
    Enpuno Biotechnology Co., Ltd
    Date Cleared
    2024-05-28

    (116 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    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. Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
    Device Description
    NRSP 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. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight. Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.
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    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
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    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
    K232182
    Device Name
    One-Fil
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2024-01-26

    (186 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent sealing of root canal
    Device Description
    One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
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