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510(k) Data Aggregation

    K Number
    K171155
    Device Name
    Surgical Angle Handpiece, Surgical Straight Handpiece
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2017-11-21

    (215 days)

    Product Code
    KMW,EGS
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K111532,K970953
    Why did this record match?
    Device Name :

    Surgical Angle Handpiece, Surgical Straight Handpiece

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).

    Device Description

    The Surgical Straight/Angle Handpiece features an allowable maximum motor speed at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed with an angle appearance and a straight appearance. Models are available to be connected directly onto motors compliant to ISO 3964. All the devices are manufactured using stainless steel with some aluminum, and use a Bur Lock Ring Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight (1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S.

    AI/ML Overview

    The provided text is a 510(k) summary for the "Nakanishi Inc. Surgical Straight/Angle Handpiece." This document describes a medical device seeking substantial equivalence to existing devices, not an AI/ML powered device. As such, it does not contain information related to acceptance criteria or studies involving AI/ML algorithms, human readers, ground truth, or training sets.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from the given text.

    The document discusses:

    • Device Name: Surgical Straight/Angle Handpiece
    • Intended Use: Oral surgical and dental use (e.g., sectioning and removal of wisdom teeth, oral surgery, implant treatment).
    • Technological Characteristics: Maximum motor speed, non-optic, Bur Lock Ring Chuck Design, materials (stainless steel, aluminum), external water supply.
    • Performance Testing: Bench testing against technical standards and internal specifications, sterilization validation (AAMI/ANSI/ISO 17665-1:2006, FDA Guidance for Reprocessing Medical Devices), biocompatibility evaluation (AAMI/ANSI/ISO 10993-1, FDA Guidance), and electrical safety (ISO 14457).
    • Conclusion: The device is considered substantially equivalent to predicate devices based on similarities in intended use, principles of operation, functional design, and established medical use.
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