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510(k) Data Aggregation

    K Number
    K113222
    Device Name
    ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
    Date Cleared
    2012-02-23

    (114 days)

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

    NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ND lowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable. ND low speed airmotor, MS-10M / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable. ND star-type straight nosecone attachment, STS-30H, is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable. ND star-type contra angle attachment, STC-20L / STU-20ML / STU-30BLP, are powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable ND highspeed airturbine handpiece, TCP-70QM / TCP-70QB / TC-80QB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. The device is autoclavable.
    Device Description
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