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510(k) Data Aggregation

    K Number
    K101612
    Device Name
    ZEN CORDLESS PROPHY SYSTEM
    Manufacturer
    DISCUS DENTAL, LLC
    Date Cleared
    2010-06-30

    (21 days)

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

    ZEN CORDLESS PROPHY SYSTEM

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

    The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

    Device Description

    The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental handpiece (Zen Cordless Prophy System). It states that the device is substantially equivalent to legally marketed predicate devices.

    The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document. This letter and its enclosure ("Indications for Use Statement") only confirm FDA clearance and describe the intended use of the device. It does not contain any details about performance studies or acceptance criteria.

    Therefore, I cannot provide the requested table or answer the specific questions based on the provided text.

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