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510(k) Data Aggregation

    K Number
    K090911
    Device Name
    IST SNORING APPLIANCE
    Manufacturer
    Date Cleared
    2009-09-11

    (163 days)

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

    DENTAL CRAFTERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories. It is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.
    Device Description
    The Dental Crafters' IST Snoring Appliance is a 2 piece upper and lower arch system designed to posture the lower jaw forward which increases the lower airway passage and alleviates snoring. It is custom-fit to a patient's teeth by a professional dentist. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) ISTplus mechanism produced by Dr Hinz Dental. The acrylic arches of the appliance are secured to the occlusal surface. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The dentist determines the position in which the lower jaw is supported in an anterior position.
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