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510(k) Data Aggregation

    K Number
    K202371
    Device Name
    Highspeed Airturbine Handpiece
    Manufacturer
    Beijing Dongbo Dental Handpiece Co., Ltd.
    Date Cleared
    2021-11-08

    (446 days)

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

    Beijing Dongbo Dental Handpiece Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry.
    Device Description
    The Highspeed Airturbine Handpiece is air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the pre-vacuum Autoclave methods. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine.
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    K Number
    K172543
    Device Name
    High-speed Turbine Handpieces for Single Use
    Manufacturer
    Beijing Dongbo Dental Handpiece Co., Ltd.
    Date Cleared
    2018-07-11

    (322 days)

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

    Beijing Dongbo Dental Handpiece Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High-speed Turbine Handpieces for Single Use are 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 High-speed Turbine Handpieces for Single Use uses compressed air as power source which drives the wind wheel in the head to make drill rotating at very high speed for teeth cutting. The proposed devices have 12 models difference includes: the size of head, methods of loading the drill, types of coupling, and shape of the shank. The High-speed Turbine Handpieces for Single Use are single use device. The device is not software driven device, does not include drill.
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