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510(k) Data Aggregation

    K Number
    K113618
    Device Name
    CLEARCORRECT SYSTEM
    Manufacturer
    CLEARCORRECT, INC.
    Date Cleared
    2012-03-19

    (103 days)

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

    CLEARCORRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
    Device Description
    The ClearCorrect device is fabricated of clear thin thermoformed polyeurathane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
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    K Number
    K082556
    Device Name
    CLEARCORRECT
    Manufacturer
    CLEARCORRECT, INC.
    Date Cleared
    2009-02-06

    (155 days)

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

    CLEARCORRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
    Device Description
    The ClearCorrect device is fabricated of clear, thin, thermoformed polycarbonate plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
    Ask a Question

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