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    K Number
    K100854
    Device Name
    PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
    Manufacturer
    PREMIUM PLUS INTERNATIONAL LIMITED
    Date Cleared
    2010-12-09

    (258 days)

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

    PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399

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

    The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device (Premium Plus Disposable Prophy Angle). It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training and test sets. This document is not relevant to those types of inquiries for AI/ML devices.

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