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510(k) Data Aggregation

    K Number
    K214054
    Device Name
    TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
    Manufacturer
    TP Orthodontics, Inc.
    Date Cleared
    2022-10-14

    (291 days)

    Product Code
    DYH, KLE
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    TP Orthodontics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment. TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
    Device Description
    TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are: - . TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant. - . TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad. The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth. TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.
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    K Number
    K111234
    Device Name
    CLICK-IT
    Manufacturer
    TP ORTHODONTICS, INC.
    Date Cleared
    2011-05-13

    (11 days)

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

    TP ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth.
    Device Description
    The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth. The basic function is the same as the orthodontic brackets for which substantial equivalence is claimed such that the movement of the tooth and remodeling of the mandibular and maxillary bone will occur when gentle sustained pressure is applied to the teeth through the bracket and wire system. The Click-It ceramic self-ligating bracket has self-ligating properties and will include maxillary and mandibular brackets from second bicuspid to second bicuspid. The device consists of a polycrystalline alumina bracket with two polycrystalline alumina jaws, a nickel titanium spring and two nickel titanium pins. The design of a self-ligating bracket enables the archwire to be ligated to the bracket without the use of auxiliary devices such as wires or elastics. It enables quicker archwire placement without any significant change in the mechanics when compared to the devices for which substantial equivalence is claimed. As its predicates, Click-It ceramic self-ligating bracket enables several types of tooth movements throughout the treatment such as: tipping, translation (bodily movement), torque, extrusion, rotation, and intrusion. The Click-It ceramic self ligating brackets are bonded to the buccal and labial surface of teeth and enable the orthodontic treatment.
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