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510(k) Data Aggregation

    K Number
    K013400
    Device Name
    SYNERGY FLOW
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2001-12-10

    (56 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNERGY FLOW

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

    Class II, IV fillings in anterior teeth; Small fillings in posterior teeth; Fillings of minimal cavities; Blocking out undercuts

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "Synergy Flow." It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses.

    Therefore, I cannot provide the requested information based on this document.

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