LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K024282
    Device Name
    ACRYLIC
    Manufacturer
    INOVATIV, LLC
    Date Cleared
    2003-03-21

    (88 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    INOVATIV, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.
    Device Description
    The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
    Ask a Question
    K Number
    K022032
    Device Name
    ACETAL
    Manufacturer
    INOVATIV, LLC
    Date Cleared
    2002-08-29

    (69 days)

    Product Code
    EHP
    Regulation Number
    872.3285
    Why did this record match?
    Applicant Name (Manufacturer) :

    INOVATIV, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
    Device Description
    The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
    Ask a Question
    K Number
    K022030
    Device Name
    POLY-CARB
    Manufacturer
    INOVATIV, LLC
    Date Cleared
    2002-08-28

    (68 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    INOVATIV, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.
    Device Description
    The Polycarb material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
    Ask a Question

    Page 1 of 1