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510(k) Data Aggregation

    K Number
    K170596
    Device Name
    TN-Brush
    Manufacturer
    GENOSS Co. Ltd.
    Date Cleared
    2017-09-11

    (195 days)

    Product Code
    ELB
    Regulation Number
    872.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOSS Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.
    Device Description
    Not Found
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    K Number
    K160079
    Device Name
    rainbow Shine
    Manufacturer
    GENOSS Co. Ltd.
    Date Cleared
    2016-11-10

    (301 days)

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

    GENOSS Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
    Device Description
    rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain. rainbow™ Shine is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2. and fitted to the patients as crowns and bridges. rainbow™ Shine is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes. rainbow™ Shine is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
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