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510(k) Data Aggregation

    K Number
    K191836
    Device Name
    Ceramill A-Splint
    Manufacturer
    Amann Girrbach AG
    Date Cleared
    2019-12-20

    (164 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Amann Girrbach AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramill A-Splint is indicated for the fabrication of removable bite splints.
    Device Description
    Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
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    K Number
    K191843
    Device Name
    Ceramill A-Temp
    Manufacturer
    Amann Girrbach AG
    Date Cleared
    2019-10-04

    (87 days)

    Product Code
    EBG, POW
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Amann Girrbach AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Temporary anterior and posterior crowns with a wearing time of maximum three years - Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years - Verifying the fit on the plaster model/mouth before the final restoration
    Device Description
    Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured. Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.
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    K Number
    K171876
    Device Name
    Ceramill Zolid HT+ white
    Manufacturer
    Amann Girrbach AG
    Date Cleared
    2017-09-20

    (89 days)

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

    Amann Girrbach AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zirconium-oxide blanks for permanent and removable dental prosthetics.
    Device Description
    Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
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