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510(k) Data Aggregation

    K Number
    K100212
    Device Name
    DENTACENTER/EXPEDITION, MODEL SAF-430
    Manufacturer
    SAFARI DENTAL, INC.
    Date Cleared
    2010-10-22

    (270 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dentacenter offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "DENTACENTER / EXPEDITION MODEL Mobile Dental Operative Unit." It describes the regulatory classification and general information about marketing the device.

    This document does not contain any information about acceptance criteria for device performance, clinical study details, or the evaluation of an AI-powered device. Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance as the necessary information is not present in the provided text.

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