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510(k) Data Aggregation

    K Number
    K212961
    Device Name
    SMILERS
    Manufacturer
    Biotech Dental Smilers, SAS
    Date Cleared
    2021-09-20

    (4 days)

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

    Biotech Dental Smilers, SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS® aligners position teeth by way of continuous gentle force.
    Device Description
    The Biotech Dental SMILERS® aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states. Biotech Dental SMILERS® sequentially reposition teeth by way of continuous gentle force.
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