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510(k) Data Aggregation

    K Number
    K182658
    Device Name
    Bioliner
    Date Cleared
    2019-06-19

    (267 days)

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

    **Five Star Orthodontic Lab **& Supply

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bioliner™ is an aligner system indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
    Device Description
    The Bioliner™ aligner system is used for treatment of misalignment and malocclusion of permanent teeth by use of clear plastic aligners. The Bioliner™ aligner system is a sequential set of removable aligners prescribed by a dentist that are custom made for a specific patient. Each Bioliner™ sequential aligner introduces subtle changes in the position of the teeth from the previous aligner. Each Bioliner™ is fabricated from 1.0mm thermoplastic. For each patient, the Bioliner™ will be designed by a Five Star Orthodontic Laboratory & Supply, Inc. technician utilizing 3Shape (K152086) orthodontic validated software and tooth movement recommendations from the prescribing dentist. Once fabricated, the Bioliner™ aligners are provided to the dentist, and over a period of time, the dentist provides the next sequential aligner to the patient in order to move the teeth to the desired final position. The aligners are removable at any time and treatment may be discontinued at any time. The Bioliner™ aligners are a non-sterile, single use device.
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