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510(k) Data Aggregation

    K Number
    K180682
    Device Name
    AeroPro Cordless Prophy System
    Manufacturer
    Premier Dental Company Products
    Date Cleared
    2019-02-27

    (349 days)

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

    AeroPro Cordless Prophy System

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

    AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

    Device Description

    AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the AeroPro™ Cordless Prophy System. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain information regarding specific acceptance criteria, performance data, or studies of the type requested (e.g., sample size, ground truth, expert qualifications, MRMC studies) as these are typically found in the 510(k) summary or detailed submission, not the clearance letter itself.

    Therefore, I cannot provide the requested information from the given text. The text only describes the device's indications for use and the regulatory clearance process.

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