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510(k) Data Aggregation

    K Number
    K233497
    Device Name
    Rest Assure System
    Manufacturer
    Somnomed, Inc.
    Date Cleared
    2024-10-03

    (338 days)

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

    Somnomed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.
    Device Description
    The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment. This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.
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