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510(k) Data Aggregation

    K Number
    K130601
    Device Name
    BIOROOT RCS
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2013-10-17

    (224 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOROOT RCS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioRoot™ RCS is intended to be used for permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioRoot™ RCS is suitable for use in single cone technique or cold lateral condensation and is reserved for professional dental use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the BioRoot™ RCS device, which confirms its substantial equivalence to a predicate device and lists its intended uses. It does not contain pre-market study data or performance metrics.

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