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510(k) Data Aggregation

    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?
    Product Code :

    EHP

    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.
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    K Number
    K983558
    Device Name
    ACETAL DENTAL/PREFORMED CLASP
    Manufacturer
    DENTAMAX, INC.
    Date Cleared
    1999-01-07

    (86 days)

    Product Code
    EHP, OCT
    Regulation Number
    872.3285
    Why did this record match?
    Product Code :

    EHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.
    Device Description
    Acetal Dental / Preformed Clasp
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    K Number
    K974622
    Device Name
    DENTAL D
    Manufacturer
    MICRO DENTAL LABORATORIES
    Date Cleared
    1998-02-10

    (61 days)

    Product Code
    EHP
    Regulation Number
    872.3285
    Why did this record match?
    Product Code :

    EHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.
    Device Description
    Not Found
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