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510(k) Data Aggregation

    K Number
    K240707
    Device Name
    Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
    Manufacturer
    Shenzhen Micro Electric Intelligence Co., Ltd.
    Date Cleared
    2024-07-02

    (109 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Micro Electric Intelligence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
    Device Description
    A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line. The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.
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