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510(k) Data Aggregation

    K Number
    K132102
    Device Name
    BECE CAD ZIRKON HT+
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    2013-11-12

    (127 days)

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

    **BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework. - Fully anatomical crowns and bridges - - Partial-veneered and fully veneered crowns and bridges - - Dentine core crowns and bridges - - Maryland bridges - - Telescopic crowns (primary part) -
    Device Description
    BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
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    K Number
    K123929
    Device Name
    BEGOPAL+
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    2013-03-14

    (84 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
    Device Description
    BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
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    K Number
    K090434
    Device Name
    BECE PRESS
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    2009-07-06

    (137 days)

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

    **BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges.
    Device Description
    BeCe PRESS is a dental ceramic system for veneering metal copings and frameworks using a press on alloy technique. The pressing ingots are composed of a two-phase leucite reinforced silicate ceramic. The restoration is processed according to the lost wax technique. The opaqued mteal framework is first waxed-up in the desired shape an function and invested. After burning out of the wax the heated, ductile BeCe PRESS ceramic is pressed into the previously created hollow space by a special ceramic press-furnace. After devesting, the restoration can be individually characterized by shade/stains and glaze materials with accompanying liquids
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    K Number
    K983081
    Device Name
    BEGOPAL 300
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    1998-10-28

    (56 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.
    Device Description
    BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.
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