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510(k) Data Aggregation

    K Number
    K083739
    Device Name
    HYDRORISE AND HYDROSYSTEM
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2009-03-26

    (100 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HYDRORISE is conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient 's teeth and gums. HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension beliore applying traditional dental impression material.
    Device Description
    Not Found
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    K Number
    K081084
    Device Name
    COLORISE RIGID
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2008-05-14

    (28 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums.
    Device Description
    COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.
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    K Number
    K080130
    Device Name
    OCCLUFAST CAD
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2008-03-14

    (56 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices. Occlufast CAD has been developed for use with CAD/CAM systems.
    Device Description
    dental impression material
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    K Number
    K073005
    Device Name
    ELITE GLASS
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2007-12-12

    (49 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070677
    Device Name
    COLORISE
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2007-05-11

    (60 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended and used to reproduce the structure of a patient`s teeth and gums.
    Device Description
    COLORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.
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    K Number
    K070700
    Device Name
    FREEALGIN
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2007-04-25

    (43 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient`s teeth and gums.
    Device Description
    FREEALGIN is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material
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    K Number
    K053619
    Device Name
    COLORBITE
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2006-03-01

    (64 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zhermack COLORBITE is a dental impression material indications Tor 650. of a patient's teeth.
    Device Description
    COLORBITE is a dental impression material.
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    K Number
    K050417
    Device Name
    ELITE IMPLANT
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2005-07-19

    (151 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.
    Device Description
    ELITE IMPLANT is a radiopaque dental impression material.
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    K Number
    K051424
    Device Name
    HYDROGUM 5
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2005-07-15

    (44 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patients teeth, inlays and dentures. It is also intended to provide models of outletted in as dental inlays and dentures.
    Device Description
    Not Found
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    K Number
    K043118
    Device Name
    HYDROGUM SOFT
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2005-01-24

    (75 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHERMACK S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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