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510(k) Data Aggregation

    K Number
    K163689
    Device Name
    3M Clear Tray Aligner
    Manufacturer
    3M Unitek Corporation
    Date Cleared
    2017-01-27

    (30 days)

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

    3M Unitek Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3MM Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
    Device Description
    The 3M Clear Tray Aligner System is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the 3M Clear Tray Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic travs intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
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    K Number
    K113197
    Device Name
    APC FLASH-FREE ADHESIVE
    Manufacturer
    3M UNITEK CORPORATION
    Date Cleared
    2012-02-02

    (94 days)

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

    3M UNITEK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
    Device Description
    It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
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    K Number
    K102803
    Device Name
    CLARITY ADVANCED CERAMIC BRACKETS
    Manufacturer
    3M UNITEK CORPORATION
    Date Cleared
    2011-02-17

    (142 days)

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

    3M UNITEK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
    Device Description
    Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
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