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510(k) Data Aggregation

    K Number
    K120619
    Device Name
    ORTHODONTIC FLOWABLE BRACKET ADHESIVE
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2012-05-21

    (82 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ORTHODONTIC FLOWABLE BRACKET ADHESIVE

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

    Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

    Device Description

    Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an Orthodontic Flowable Bracket Adhesive. It does not contain information about acceptance criteria or a study proving device performance as requested. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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