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510(k) Data Aggregation

    K Number
    K180107
    Device Name
    Blue Sky Bio Aligner
    Manufacturer
    Blue Sky Bio LLC
    Date Cleared
    2018-02-09

    (24 days)

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

    Blue Sky Bio LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue Sky Bio Aligners are 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
    Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions. A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, 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 health 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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