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510(k) Data Aggregation

    K Number
    K013859
    Device Name
    RHODIA BITE REGISTRATION MATERIAL
    Manufacturer
    Date Cleared
    2002-01-29

    (69 days)

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

    RHODIA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.
    Device Description
    The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto a tray. The material quickly cures into a rigid impression.
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    K Number
    K013129
    Device Name
    RHODIA DENTAL PUTTY IMPRESSION MATERIAL
    Manufacturer
    Date Cleared
    2001-10-10

    (21 days)

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

    RHODIA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rhodia Putty Dental Impression Materials are intended for use for first impression in the technique of double impression.
    Device Description
    Rhodia Putty is used for first impression in the technique of the double impression. It can be used with perforated and non-perforated trays constructed of metal or plastic. The device is a two-part vinyl polysiloxane putty with an addition-cure reaction. The base and catalyst components are mixed together prior to creating an impression.
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    K Number
    K013140
    Device Name
    RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
    Manufacturer
    Date Cleared
    2001-10-10

    (21 days)

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

    RHODIA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.
    Device Description
    Rhodia hydrophilic dental impression material is intended for use for making intra-oral impressions. The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the surfaces of the teeth or onto a tray. The material quickly cures into a rigid impression. The hydrophilic property of the dental impression material helps to capture and reproduce perfect detail even in a moist environment.
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