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510(k) Data Aggregation

    K Number
    K093821
    Device Name
    FS ALIGNER
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Date Cleared
    2010-08-27

    (256 days)

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

    ALLESEE ORTHODONTIC APPLIANCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.
    Device Description
    FS Aligner is an aligner system which offers a solution to those patients who want a simple, aesthetic system of removable aligners to correct minor anterior mal-alignments in patients with permanent dentition (second molars) without the use of conventional wire and bracket orthodontic technology. The system consists of a series of clear, lightweight, flexible, plastic aligners. Each aligner applies incremental progressive force to reposition teeth to a more ideal alignment as prescribed by the treating dental practitioner.
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    K Number
    K040874
    Device Name
    RED, WHITE & BLUE
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Date Cleared
    2004-06-18

    (77 days)

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

    ALLESEE ORTHODONTIC APPLIANCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to internediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state.
    Device Description
    Red, White & Blue is a relainer system which offers a solution to those patients who want a simple, aesthetic system to correct minor to intermediate tooth mal-alignments without the use of conventional wire and brucket orthodontic technology. The system consists of a scrics of three, clear lightweight, plastic retainers. Each appliance applics incremental tooth correction by means of repositioning the anterior teeth. In this way, the patient's tecth will get progressively closer to the desired final state. The dental practitioner will make dental improssions of his patient's tecth and select the anterior tecth that are to be repositioned. The impressions or a model of the tecth made from the improssion is then sent to AOA along with a prescription form. The teeth selected for treatment are cut from the model and progressively repositioned. After each repositioning, AOA will create a corresponding appliance for a total of three active appliances. Depending upon the complexity of the case, it is possible that a patient may require less or more than the series of three appliances. The Red, White & Blue retainers are mailed to the dental practitioner, who in turn, will provide them to their patient with the instructions for use.
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