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510(k) Data Aggregation

    K Number
    K202952
    Device Name
    Amber Mill Q Series & Amber Mill Direct Series
    Manufacturer
    HASS Corp.
    Date Cleared
    2021-08-26

    (330 days)

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

    HASS Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Once finalized into a suitable design, the Amber Mill O Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
    Device Description
    Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the form of Blocks. Amber Mill O Series & Amber Mill Direct Series can be fabricated using CAD/CAM technologies. The subject devices are intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The subject devices are glass type material used for aesthetic purposes of veneers, inlays, onlays, single-unit anterior and posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 18 different size/shape series and each series offers 45 different shades. 18 different sizes are to be used with various equipment for CAD/CAM milling and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patient's tooth colors. The subject devices don't need sintering since they are provided fully crystallized. The only difference between Amber Mill Q Series and Amber Mill Direct Series is that the Amber Mill Q series has a hole in the center combined with a zirconia cap. The holes in Amber Mill Q are sizes compatible with abutment, through which are bonded to abutment to be connected to the implant.
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    K Number
    K160102
    Device Name
    Amber Mill Series and Amber Press Series
    Manufacturer
    HASS CORP.
    Date Cleared
    2016-07-14

    (177 days)

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

    HASS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System. Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
    Device Description
    Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique. This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.
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    K Number
    K111573
    Device Name
    MONOBLOC BM SERIES
    Manufacturer
    HASS CORP.
    Date Cleared
    2011-08-26

    (81 days)

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

    HASS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
    Device Description
    MonoBloc BM Series is glass type material used for aesthetic purposes of inlays, onlays, veneers and crowns. This looks like a block form and corresponds to ISO 6872 Type 2 Class 1. It can be fabricated using dental CAD/CAM devices such as CERECTM inLab and CERECTM MCXL.
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    K Number
    K102305
    Device Name
    HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
    Manufacturer
    HASS CORP.
    Date Cleared
    2010-12-03

    (109 days)

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

    HASS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
    Device Description
    HASS Zirtooth is a zirconia porcelain product to be used to make the core of the all porcelain crown. It consists of ceramic blocks and corresponds to ISO 6872 Type 2 Class 1. This ceramic product provides the supporting structure for mounting the ceramic restoration. The shelf life of the ceramic block is semi-permanent.
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