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

    DENTEK LD 15 LASERSYSTEM

    K Number: K974057 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    176

    Basic Information

    Device Name
    DENTEK LD 15 LASERSYSTEM
    K Number
    K974057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
    Date Received
    October 27, 1997
    Decision Date
    April 21, 1998
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.

    K Number Device Name
    K990680 DENTEC LD 15 DIODE LASER