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    K Number
    K113222
    Device Name
    ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
    Manufacturer
    NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
    Date Cleared
    2012-02-23

    (114 days)

    Product Code
    EFB,EGS,IND
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for dental handpieces and accessories. It does not describe an AI/ML-driven medical device or a study proving its performance against acceptance criteria.

    The information you are asking for, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies, is not present in this type of regulatory document. This document is related to traditional medical devices (dental handpieces) and their substantial equivalence to previously marketed devices based on their intended use and technological characteristics, not on software performance or clinical study results for novel AI algorithms.

    Therefore, I cannot provide the requested information based on the provided text.

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