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510(k) Data Aggregation

    K Number
    K252890

    Validate with FDA (Live)

    Device Name
    ZenSeal Pro
    Manufacturer
    Kerr Corporation
    Date Cleared
    2026-01-07

    (118 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K190503,K080917
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Permanent obturation of the root canal.
    ZenSeal Pro is intended for root canal sealing after the removal of infected or necrotic pulp tissue.

    ZenSeal Pro is suitable for use in the warm vertical condensation, single cone, cold lateral condensation and gutta-percha carrier obturator technique.

    Device Description

    ZenSeal Pro is a Bioceramic root canal sealer based of calcium silicate making it a bioceramic material. The device is a single syringe barrel, insoluble, radiopaque material, which requires the presence of water to set and harden. It is delivered into the canal with the use of disposable tips provided in the package or it can be delivered via the gutta-percha paper point or file method.

    ZenSeal Pro is used for permanent obturation of the root canal space with the aid of obturating points.

    It is suitable for use in the warm vertical condensation, single cone, cold lateral condensation and gutta-percha carrier obturator technique.

    ZenSeal Pro consists of one (1) syringe with 1.8 grams of paste and twenty (20) single use ZenSeal Pro Trimmable Tips also known as disposable delivery tips. Tips are also offered separately as an accessory.

    AI/ML Overview

    N/A

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