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510(k) Data Aggregation

    K Number
    K140877
    Device Name
    VERICORE ZIRCONIA BLANKS
    Manufacturer
    WHIP MIX CORP.
    Date Cleared
    2014-09-03

    (149 days)

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

    WHIP MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate; - -Zirconia Substructures - Restorations (Including inlays, onlays, and veneers) - - -Crown Framework in the Anterior and Posterior regions - -Bridge Framework in the Anterior and Posterior regions
    Device Description
    Vericore Zirconia Blanks is a device made from pre-pressed and pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.
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    K Number
    K140146
    Device Name
    COMFORTSOFT SOFT DENTURE LINER SYSTEM
    Manufacturer
    WHIP MIX CORP.
    Date Cleared
    2014-04-29

    (97 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHIP MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.
    Device Description
    ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.
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