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510(k) Data Aggregation

    K Number
    K122069
    Device Name
    STORM MINI SCREW
    Manufacturer
    LANCER ORTHODONTICS, INC.
    Date Cleared
    2013-04-11

    (269 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANCER ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
    Device Description
    The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed to be immediately used as an anchorage for orthodontic devices. The Storm mini-screw head is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
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    K Number
    K071192
    Device Name
    BLUGOO HD
    Manufacturer
    LANCER ORTHODONTICS, INC.
    Date Cleared
    2007-06-22

    (53 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANCER ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
    Device Description
    Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.
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    K Number
    K051552
    Device Name
    O.A.S.I. SYSTEM
    Manufacturer
    LANCER ORTHODONTICS, INC.
    Date Cleared
    2005-09-19

    (98 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANCER ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is intended for use in patients where orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
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    K Number
    K991481
    Device Name
    PARAGON
    Manufacturer
    LANCER ORTHODONTICS, INC.
    Date Cleared
    1999-08-11

    (105 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANCER ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    paragon, a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.
    Device Description
    a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.
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