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510(k) Data Aggregation

    K Number
    K251389

    Validate with FDA (Live)

    Device Name
    High speed air turbine handpiece
    Manufacturer
    Foshan Topmed Dental Co., Ltd.
    Date Cleared
    2026-01-12

    (252 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K170229
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    High-speed air turbine handpiece 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

    High-speed Turbine Air Handpiece is an instrument for drilling, grinding, repairing utilized in dental clinics. It composed of a head, a handle and a connector.

    The subject device is intended to be used for dental professional use only.

    Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). The user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

    AI/ML Overview

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