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510(k) Data Aggregation

    K Number
    K242386
    Device Name
    Bluemoon
    Manufacturer
    GENOSS Co., Ltd.
    Date Cleared
    2025-05-05

    (266 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOSS Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
    Device Description
    The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
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    K Number
    K222688
    Device Name
    The Trust
    Manufacturer
    Genoss Co., Ltd
    Date Cleared
    2024-08-09

    (703 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoss Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.
    Device Description
    This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.
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    K Number
    K233885
    Device Name
    rainbow Paste Stain SE
    Manufacturer
    Genoss Co., Ltd.
    Date Cleared
    2024-06-21

    (196 days)

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

    Genoss Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    rainbow Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
    Device Description
    rainbow™ Paste Stain SE is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.
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    K Number
    K232174
    Device Name
    rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
    Manufacturer
    Genoss Co., Ltd.
    Date Cleared
    2024-02-23

    (217 days)

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

    Genoss Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
    Device Description
    rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2. rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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™ Multi-Layer Block / bright 3-Layer / bright Mono 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 anterior crowns, posterior crowns, bridges rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono 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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    K Number
    K231480
    Device Name
    Bright MTA Sealer Plus
    Manufacturer
    Genoss Co., Ltd.
    Date Cleared
    2023-07-28

    (67 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoss Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bright MTA Sealer Plus is used for filling root canals.
    Device Description
    Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals.
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    K Number
    K214086
    Device Name
    Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
    Manufacturer
    Genoss Co., Ltd.
    Date Cleared
    2022-12-15

    (353 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoss Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression
    Device Description
    Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.
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    K Number
    K200155
    Device Name
    Bright High Flow
    Manufacturer
    GENOSS Co., Ltd.
    Date Cleared
    2020-11-30

    (313 days)

    Product Code
    EBF, EBC
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOSS Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Base/liner 2) Pit & Fissure sealant
    Device Description
    Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
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    K Number
    K200153
    Device Name
    Bright Bond Universal
    Manufacturer
    GENOSS Co., Ltd.
    Date Cleared
    2020-10-28

    (280 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOSS Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Direct bonding for light-cured composites to tooth surface 2) Bonding of dual-cured core build up composites to tooth surface 3) Intraoral repair of composite, PFM and ceramic restoration using cements 4) Sealing of tooth preparation for indirect restoration
    Device Description
    Bright Bond Universal is a light-cured dental adhesive that combines etching, priming, and bonding functions in a single bottle solution. It provides strong and durable bonds between dentin/enamel and light-curable direct/indirect restorative materials.
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    K Number
    K200156
    Device Name
    Bright Low Flow
    Manufacturer
    Genoss co.,Ltd.
    Date Cleared
    2020-10-27

    (279 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoss co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Class I, III, V (non-stress area, minimally invasive restoration) 2) Composite resin repair
    Device Description
    Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
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    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

    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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