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510(k) Data Aggregation

    K Number
    K220688
    Device Name
    SilentZPro 2.0
    Manufacturer
    Shinrin-Yoku Traders LLC
    Date Cleared
    2022-12-02

    (269 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shinrin-Yoku Traders LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SilentZPro 2.0 is intended as an aid in the reduction of snoring for adults at least 18 years old.
    Device Description
    SilentZPro 2.0 is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.
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