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510(k) Data Aggregation

    K Number
    K192649
    Device Name
    Endo Motor
    Manufacturer
    Foshan CICADA Dental Instrument Co., Ltd.
    Date Cleared
    2021-03-12

    (535 days)

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

    Foshan CICADA Dental Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.
    Device Description
    Cordless endo motor is a professional equipment for root canal preparation. It is a drive for contra angle headpiece which is designed to assist dentists and dental surgeons perform standard endodontic procedures. The endo motor consists of Cordless main unit, Charger station and Adapter. It is intended to use with FDA cleared contra-angle handpiece (transmission ratio of contra angle handpiece: 16:1) which would hold the drill bit or file. However the device do not included the contra angle handpiece and files. The Endo smart is equipped with rechargeable Li-ion battery, which can be recharged using the provided charge station. By means of the different buttons on the main unit, the user could control various functions in the device, such as On/off, Speed, Torque and auto-reverse/auto forward mode. The Endo motor is not sterile and cannot be autoclaved.
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    K Number
    K192233
    Device Name
    LED Curing Light
    Manufacturer
    Foshan CICADA Dental Instrument Co., Ltd.
    Date Cleared
    2020-02-13

    (178 days)

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

    Foshan CICADA Dental Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
    Device Description
    LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site. LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button. LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market. The enclosure of main unit was composed of ABS material and Aluminum, and the light guide base (patient contact part) was made from ABS material.
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    K Number
    K181900
    Device Name
    Dental high speed handpiece, Dental low speed handpiece
    Manufacturer
    Foshan CICADA Dental Instrument Co., Ltd.
    Date Cleared
    2019-12-09

    (511 days)

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

    Foshan CICADA Dental Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental high speed handpiece: Is intended for removing carious material, reducing hard tooth structure, cavity and crown preparations, removal of fillings, finishing tooth preparations, restoration and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry. Dental low speed handpiece: Is intended for preparing dental cavities and crown for restorations, and teeth cutting, restorations and polishing teeth. The device is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Not Found
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