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510(k) Data Aggregation

    K Number
    K111809
    Device Name
    SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
    Manufacturer
    BIOMATERIALS KOREA INC.
    Date Cleared
    2011-09-26

    (91 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

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

    The SL Type and SPL Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes an FDA 510(k) clearance letter for SL Type and SPL Type Orthodontic Screws. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices for its stated indications for use.

    Therefore, I cannot provide the requested information.

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