BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

    K Number: K011769 · Decision Aug 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
    K Number
    K011769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Opusdent , Ltd.
    Date Received
    June 7, 2001
    Decision Date
    August 30, 2001
    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 Opusdent , Ltd.

    K Number Device Name
    K021508 OPUSDUO EC DENTAL LASER SYSTEM
    K014100 OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
    K002899 OPUS 20, MODEL 1ST
    K000990 OPUS 10 DENTAL DIODE LASER