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510(k) Data Aggregation

    K Number
    K251869
    Device Name
    Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
    Manufacturer
    Premium Plus (Dongguan) Limited
    Date Cleared
    2025-09-15

    (89 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K100854
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable Prophy Angle is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. It is intended for single use, and should be discarded after each patient.

    Device Description

    Disposable Prophy Angle is a dental rotational device that consists of a prophy cup, a plastic body, a gear and a shaft with gear, which connects to a low-speed dental handpiece. The gear has the prophy cup attached to the end which holds dental tooth polishing paste. Prophy Angle is held in a dental handpiece by a shaft, which rotates the device's gear at speed as the polishing/ cleaning paste is applied to the surface of the teeth.

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