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510(k) Data Aggregation

    K Number
    K243911
    Device Name
    HPR Cordless Hygiene Handpiece
    Manufacturer
    Handpiece Headquarters
    Date Cleared
    2024-12-20

    (1 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HPR Cordless Hygiene Handpiece

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

    The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control. It is designed for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.

    Device Description

    The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for a medical device. These details are typically found in the 510(k) submission itself or in a summary of safety and effectiveness, which is not included in this document.

    Therefore, I cannot extract the requested information from the given input.

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