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510(k) Data Aggregation

    K Number
    K130991
    Device Name
    NEXXZR(TM)T AND NEXXZR(TM)S
    Manufacturer
    SAGEMAX BIOCERAMICS, INC.
    Date Cleared
    2014-02-10

    (306 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGEMAX BIOCERAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NexxZr T and NexxZr S are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
    Device Description
    Sagemax NexxZr™ T and NexxZr™ S are zirconium dioxide-yttrium oxide ceramic material - pressed into pre-sintered discs intended for further processing using computer aided manufacturing by a dental laboratory or other similar establishment, under the order of a physician/dentist. The dentist prepares the surface(s) of the natural teeth, then cements (lutes) the restoration in place with standard dental adhesives materials. Sagemax NexxZr™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers. The material is radioopaque, for ready visualization. NexxZr™ products are a modification of the previous version, Sagemax Z-Blank™
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    K Number
    K062695
    Device Name
    SAGEMAX Z-BLANK
    Manufacturer
    SAGEMAX BIOCERAMICS, INC.
    Date Cleared
    2006-10-20

    (39 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGEMAX BIOCERAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use in preparation of crowns, facings, inlays and onlays-to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
    Device Description
    Sagemax Z-Blank™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Sagemax Z-Blank "" prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opague, for ready visualization.
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