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510(k) Data Aggregation

    K Number
    K230641
    Device Name
    Ultrasonic Scaler Tips
    Manufacturer
    Guilin Refine Medical Instrument Co., Ltd.
    Date Cleared
    2023-11-21

    (258 days)

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

    Guilin Refine Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasonic scaler tips are intended for use by dental professionals to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Clean and irrigate root canals.
    Device Description
    Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair. The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread. GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.
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    K Number
    K223414
    Device Name
    Curing Light, Model: MaxCure 9
    Manufacturer
    Guilin Refine Medical Instrument Co., Ltd.
    Date Cleared
    2023-11-15

    (370 days)

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

    Guilin Refine Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.
    Device Description
    This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.
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