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510(k) Data Aggregation

    K Number
    K150128
    Device Name
    GC Ortho Connect, GC Ortho Etching Gel
    Manufacturer
    GC Orthodontics America Inc.
    Date Cleared
    2015-07-16

    (177 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GC Ortho Connect

      1. Bonding metal brackets and attachments
      1. Bonding ceramic brackets
      1. Bonding plastic brackets and acrylic appliances

    GC Ortho Etching Gel

      1. Etching enamel of tooth surfaces
      1. Enhancing the bond strength of light-cured orthodontic adhesive materials
    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for two dental products: GC Ortho Connect and GC Ortho Etching Gel. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document.

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