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510(k) Data Aggregation

    K Number
    K213088
    Device Name
    ZQuiet Advance
    Manufacturer
    Sleeping Well, LLC
    Date Cleared
    2022-06-15

    (264 days)

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

    Sleeping Well, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.
    Device Description
    The ZQuiet Advance is an intraoral appliance designed to reduce snoring by advancing the lower jaw. The principal effect of mandibular advancement devices is the protrusion of the lower jaw, thereby widening the upper airway to decrease air turbulence, a causative factor in snoring. This device combines several essential functions: Separate upper and lower dental trays with thermal impression material to engage the upper and lower dentition, a mechanism to provide the forward positioning of the lower jaw relative to the upper jaw in 3 positions determined by the user's bite providing up to +6 mm of possible advancement. The design allows the maintenance of the forward positioning of the lower jaw while allowing minor sagittal and vertical movement. The ZQuiet Advance is a "Boil-and-Bite" device that uses thermal impression resin for device retention. The upper and lower trays are both constructed out of a rigid plastic outer tray to provide the device structure and attachment points for the connecting semi-rigid straps that provide the adjustability. Both the upper and lower trays are lined with material that is moldable when heated in a water bath and provides the ability to conform the device to the individual's teeth.
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    K Number
    K140777
    Device Name
    ZQUIET-SA
    Manufacturer
    SLEEPING WELL, LLC
    Date Cleared
    2014-07-25

    (119 days)

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

    SLEEPING WELL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZQuiet-SA is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.
    Device Description
    The ZQuiet-SA oral appliance consists of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in multiple models allowing the dentist to recommend different degrees of mandibular advancement and preference of anterior posts.
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    K Number
    K122475
    Device Name
    ZQUIET PRO-PLUS
    Manufacturer
    SLEEPING WELL, LLC
    Date Cleared
    2012-12-07

    (115 days)

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

    SLEEPING WELL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
    Device Description
    The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.
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    K Number
    K093407
    Device Name
    ZQUIET MOUTHPIECE
    Manufacturer
    SLEEPING WELL, LLC
    Date Cleared
    2010-06-22

    (232 days)

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

    SLEEPING WELL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.
    Device Description
    The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device. The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.
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    K Number
    K090503
    Device Name
    ZQUIET MOUTHPIECE
    Manufacturer
    SLEEPING WELL, LLC
    Date Cleared
    2009-03-10

    (13 days)

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

    SLEEPING WELL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults. The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.
    Device Description
    The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of : - Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates. - The device is made of Thermoplastic elastomer . - ◆ May be used as supplied
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