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510(k) Data Aggregation

    K Number
    K980018
    Device Name
    CRISTOBAL
    Date Cleared
    1998-05-19

    (137 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEWAVE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include: - single crowns, - telescope crowns, - conus crowns, - bridges, - Maryland bridges, - bridges on implants, - inlays, - onlays - facettes (laminate veneers), and - restorations.
    Device Description
    CRISTOBAL consists of a series of layered composite restorative glass strength materials, combining the benefit of porcelain, composite and dental alloys, whose combined properties of wear resistance, flexural strength, maximum compressive strength and bulk modulus, make it suitable for all types of fixed cosmetic prosthetic restorations. CRISTOBAL offers the patient a tooth colored occlusal surface with the feeling of natural teeth. CRISTOBAL is subject to complete polymerization for optimal reactions of the various materials. Due to the fact that the light curing material of CRISTOBAL is radioand its matrix has a very high content in inorganic particles (barium opaque. borosilicate), it allows for the production of fixed prostheses with functional, mechanical, and cosmetic longevity. CRISTOBAL is composed of silanized barium borosilicate particles, a non-fracturable filler material, which are closely packed (74.2 weight percent) providing optimal silanization and cohesion of glass thereby ensuring protection against fracture together, with strong resistance to damage. With the matrix of Bis-GMA, TEDMA and UDDMA, these elastic memory properties also ensure damage resistance.
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