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510(k) Data Aggregation

    K Number
    K251283
    Device Name
    Once-Fil Flow
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-06-06

    (42 days)

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

    Mediclus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Temporary inlay and onlay treatments of the cavity. - Sealing of openings for implant screws. - Relining material for temporary crowns and bridges. - Covering of the gingival margin - Fixing of resin matrix during filling placement. - Block-out material for retentive ares in the dental arch, e.g. before taking impressions.
    Device Description
    Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases. To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration. The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.
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    K Number
    K250823
    Device Name
    Any-Com Flow
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-04-14

    (27 days)

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

    Mediclus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Anterior and posterior restorations. - Indirect restorations for Inlays, onlays and veneers.
    Device Description
    Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth. The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICLUS CO., LTD.

    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
    K242713
    Device Name
    Any-Com Bulk
    Manufacturer
    MEDICLUS CO., LTD.
    Date Cleared
    2025-02-07

    (151 days)

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

    MEDICLUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Base under Class I and Class II direct restorations - Liner under direct restorative materials - Restoration of small cavities - Class III and V restorations - Core build-ups
    Device Description
    Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment. The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
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    K Number
    K241147
    Device Name
    Any-Com
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2024-09-26

    (154 days)

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

    Mediclus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Anterior and posterior restorations - Core build-up - Indirect restorations for inlays, onlays and veneers.
    Device Description
    Any-Com is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth. The product offers a wide range of options with a total of 20 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process for the selected shade, Any-Com is applied to the teeth using suitable instruments and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediclus Co., Ltd.

    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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    K Number
    K230465
    Device Name
    Hi-Bond Universal
    Manufacturer
    Mediclus Co., LTD.
    Date Cleared
    2023-05-22

    (90 days)

    Product Code
    KLE, EBF, LBH
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediclus Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. all direct restorations - 2. all indirect restorations - 3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites) - 4. desensitizing/sealing of tooth structure - 5. protective varnish for glass ionomer fillings - 6. priming of enamel for orthodontic use
    Device Description
    The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.
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