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510(k) Data Aggregation

    K Number
    K160410
    Device Name
    WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
    Manufacturer
    Dental Savings Club
    Date Cleared
    2016-09-29

    (226 days)

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

    WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

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

    WOlf High Speed Handpieces are used intra-orally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

    Device Description

    WOlf High Speed Handpieces

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a dental handpiece. It does not contain any information regarding acceptance criteria, performance studies, or clinical validation data for the WOlf High Speed Handpieces.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document primarily focuses on:

    • The FDA's determination of substantial equivalence.
    • Regulatory requirements for the device.
    • Indications for Use.
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