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510(k) Data Aggregation

    K Number
    K241074
    Device Name
    High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
    Manufacturer
    Foshan SOCO Precision Instrument Co.,Ltd.
    Date Cleared
    2024-11-12

    (207 days)

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

    Foshan SOCO Precision Instrument Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
    Device Description
    The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.
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