LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012142
    Device Name
    THE QUIET SLEEPER
    Manufacturer
    PRECISION DENTAL LABORATORIES, INC.
    Date Cleared
    2001-10-04

    (86 days)

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

    PRECISION DENTAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The "Quiet Sleeper" is intended to reduce the severity of snoring, and mild to moderate obstructive sleep apnea. Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1