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

    PM POSITIONER

    K Number: K953293 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PM POSITIONER
    K Number
    K953293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jonathan A. Parker, D.D.S.
    Date Received
    July 14, 1995
    Decision Date
    September 15, 1995
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LQZ), ordered by most recent decision date.

    AIO Breathe

    FDA 510(k)
    FDA Class 2 ·Dental

    RADx Intraoral Appliance for Snoring and Sleep Apnea

    FDA 510(k)
    FDA Class 2 ·Dental

    The Slide

    FDA 510(k)
    FDA Class 2 ·Dental

    Slow Wave DS8

    FDA 510(k)
    FDA Class 2 ·Dental

    The NightBlocks Appliance

    FDA 510(k)
    FDA Class 2 ·Dental

    SML-OSA2 Appliances

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Jonathan A. Parker, D.D.S.

    K Number Device Name
    K955503 ADJUSTABLE PM POSITIONER