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510(k) Data Aggregation

    K Number
    K092494
    Device Name
    GEL FILLED GUM SOOTHER
    Manufacturer
    LUV N' CARE, LTD.
    Date Cleared
    2010-03-01

    (199 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GEL FILLED GUM SOOTHER

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

    The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.

    Device Description

    Teething Ring – Water or Gel Filled

    AI/ML Overview

    This document is a 510(k) premarket notification for a Teething Ring - Water or Gel Filled. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way medical device AI/software studies typically do.

    The FDA 510(k) clearance process for this type of device (a physical teething ring) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring specific performance studies with quantitative metrics like sensitivity, specificity, or reader improvement.

    Therefore, I cannot provide the requested information because it is not present in the provided text. The document is primarily a regulatory clearance letter and an "Indications For Use" statement.

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