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510(k) Data Aggregation

    K Number
    K251465
    Device Name
    Root canal repair materials (nRoot BP)
    Manufacturer
    Enpuno Biotechnology Co., Ltd
    Date Cleared
    2025-09-25

    (135 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K092715
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Root canal repair materials (nRoot BP) 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

    The root canal repair material is a pre mixed paste material containing an inorganic powder system and an organic mixed liquid. Can solidify in a bodily fluid environment and effectively repair root canals; Has excellent X-ray blocking properties, stable curing time, and does not stain teeth. nRoot BP is packaged in a preloaded syringe.

    The performance of the Root canal repair materials conforms to ISO 6876:2012 Dentistry- Root canal sealing materials.

    AI/ML Overview

    N/A

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