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510(k) Data Aggregation

    K Number
    K150702
    Device Name
    Exceed Tx
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2016-03-24

    (372 days)

    Product Code
    DYW, EJF, NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREAT LAKES ORTHODONTICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.
    Device Description
    The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patients Orthodontist. Commercially available brackets are used as part of the system. Using the images provided by the Dental Professional, the software creates a 3D model and identifies the ideal placement of the brackets. The file is sent to the Dental Professional for review and approval. The Dental Professional may adjust the final position of the bracket if desired. A 3D model is printed, and the brackets are placed on the model in the prescribed location, approved by the Orthodontist. An indirect bonding tray is fabricated with the brackets in place. The tray and brackets are sent to the Dental professional. The Dental Professional places the indirect tray using their chosen commercially available bracket adhesive.
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    K Number
    K083479
    Device Name
    BIOCRYL X
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2009-02-27

    (95 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREAT LAKES ORTHODONTICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biocryl X is intended for the laboratory fabrication of radiographic templates to be worn by a patient during x-ray imaging. Biocryl X is indicated for the fabrication of dental radiographic templates worn during x-ray imaging.
    Device Description
    Biocryl X is a radiopaque, auto-polymerizing powder/liquid dental acrylic system.
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    K Number
    K041718
    Device Name
    KELES FACEMASK
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2004-10-15

    (113 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREAT LAKES ORTHODONTICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.
    Device Description
    The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.
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    K Number
    K040881
    Device Name
    METACRYL
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2004-05-25

    (50 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREAT LAKES ORTHODONTICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Metacryl ™ is intended for the chairside fabrication of soft relines for dentures.
    Device Description
    Metacryl is a chemically cured soft denture reline. All components have been used in legally marketed devices or have been found to be safe for dental use.
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    K Number
    K033632
    Device Name
    VARIFLEX
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2004-01-21

    (63 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREAT LAKES ORTHODONTICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Variflex™ is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
    Device Description
    Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
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