BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

    K Number: K061228 · Decision May 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    24

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    Basic Information

    Device Name
    FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
    K Number
    K061228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bryan Keropian Dds
    Date Received
    May 2, 2006
    Decision Date
    May 26, 2006
    Product Code
    LQZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LQZ Device, Jaw Repositioning

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    Other Clearances by Bryan Keropian Dds

    K Number Device Name
    K091035 FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
    K053065 FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
    K052862 FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)