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510(k) Data Aggregation

    K Number
    K213757
    Device Name
    Endocem MTA Premixed Regular
    Manufacturer
    Maruchi
    Date Cleared
    2023-02-14

    (441 days)

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

    Maruchi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.
    Device Description
    ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.
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    K Number
    K212229
    Device Name
    White Endoseal MTA
    Manufacturer
    MARUCHI
    Date Cleared
    2021-08-13

    (28 days)

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

    MARUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent root canal obturation
    Device Description
    White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.
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    K Number
    K202015
    Device Name
    White ENDOSEAL MTA
    Manufacturer
    Maruchi
    Date Cleared
    2021-03-24

    (246 days)

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

    Maruchi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent root canal obturation
    Device Description
    This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.
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    K Number
    K201799
    Device Name
    CleaniCal
    Manufacturer
    Maruchi
    Date Cleared
    2021-02-12

    (227 days)

    Product Code
    EJK, KIF
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Maruchi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including: * Temporary disinfectant dressings in the obturation of root canals; * Indirect pulp capping or management of deep caries lesions; or * Direct pulp capping.
    Device Description
    CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.
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    K Number
    K170175
    Device Name
    ENDOSEAL MTA
    Manufacturer
    MARUCHI
    Date Cleared
    2018-02-26

    (403 days)

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

    MARUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Permanent obturation of the root canal following vital pulp-extirpation - Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
    Device Description
    ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.
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    K Number
    K133042
    Device Name
    ENDOCEM ZR
    Manufacturer
    MARUCHI
    Date Cleared
    2014-05-12

    (227 days)

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

    MARUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - A root-end filling material - For the repair of root canals as an apical plug during apexification - For repair of root perforations during root canal therapy - As a consequence of internal resorption - As a pulp capping material - For the filling of pulpotomy of deciduous tooth
    Device Description
    The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and is used in a putty form which gradually hardens in the oral environment.
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    K Number
    K133054
    Device Name
    ENDOSEAL
    Manufacturer
    MARUCHI
    Date Cleared
    2014-05-12

    (227 days)

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

    MARUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - . Repair of perforation - . Root canal filling
    Device Description
    The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.
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    K Number
    K112078
    Device Name
    ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
    Manufacturer
    MARUCHI
    Date Cleared
    2012-03-19

    (242 days)

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

    MARUCHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - A root-end filling material - For the repair of root canals as an apical plug during apexification - For repair of root perforations during root canal therapy - As a consequence of internal resorption - As a pulp capping material - For the filling of pulpotomy of deciduous tooth
    Device Description
    This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.
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