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510(k) Data Aggregation

    K Number
    K140976
    Device Name
    ENADEN FLOW
    Manufacturer
    Date Cleared
    2014-07-10

    (85 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    KM CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Enaden Flow is intended for use in : 1) Restoration of class I~V cavities 2) Blocking out of undercuts 3) Sealing hypersensitive areas
    Device Description
    Enaden Flow is a polymer-based restorative material. Enaden Flow is visible light-cured, radiopaque flowable composite and it is easy to handle, ready to be applied to restorations directly. The Enaden Flowl is available in 5 shades: A1, A2, A3, A3.5, and B2 (according to VITAPAN® classic shade guide). The device is used for the restorations of both anterior and posterior teeth. The device is contained in a plastic syringe and the system includes a plunger, disposable needle, protective cap, and a holder for direction control of the needle.
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    K Number
    K133716
    Device Name
    TRC-PASTE
    Manufacturer
    Date Cleared
    2014-04-09

    (125 days)

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

    KM CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.
    Device Description
    TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.
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    K Number
    K132123
    Device Name
    TRC-PEX, RADIC-SEALER
    Manufacturer
    Date Cleared
    2014-03-20

    (253 days)

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

    KM CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TRC-Pex: The TRC-Pex is a temporary root canal sealer for use in the treatment of root canals, following a pulpectomy or for apexegenesis or apexification. Radic-Sealer: The Radic-Sealer is a root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    TRC-Pex: TRC-Pex is an immediately available pre-mixed root canal filling material based on Calcium Hydroxide and lodoform. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip. Radic-Sealer: Radic-Sealer is a root canal sealing & filling material based on epoxy-amine resin. Radic-Sealer is contained in a dual syringe which makes it easy to mix and inject. It makes permanent obturation of root canals using adhesion properties between root canal walls and the root canal filling materials. The base and catalyst are contained separately in the chambers of two separate plastic syringes. The product consists of a mixing tip with a mixing joint, a protective cap, a mixing pad, and a plunger.
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