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510(k) Data Aggregation

    K Number
    K990756
    Device Name
    FLOW LINE
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    1999-05-07

    (60 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K994304
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This material is intended for extended pit and fissure sealing; class V restoration, minimal invasive restorations of class I, II and III; slight form and shade corrections of enamel; splinting of teeth after traumatic impact; adjustments of congenital tooth defects (e.g. enamel hypoplasis); cavity lining in class I and II restorations.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, approving a dental device called "Flow Line." It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, ground truth, etc.). This type of FDA letter confirms that a device is substantially equivalent to a predicate device, allowing it to be marketed, but does not typically include the detailed study results that would satisfy your request.

    Therefore, I cannot extract the requested information from the provided text.

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