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510(k) Data Aggregation

    K Number
    K182388
    Device Name
    Krystal Klear Aligners
    Date Cleared
    2019-12-19

    (471 days)

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

    Shatkin F.I.R.S.T. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Krystal Klear Aligners System is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align teeth over a period of several months. The aligners are completely removeable by the patient and may be discontinued at any time.
    Device Description
    The Krystal Klear device is fabricated of clear, thin, thermoformed copolyester plastic in a sequential series to progressively reposition teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
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