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

    EMS PIEZON MASTER 600

    K Number: K022328 · Decision Aug 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    9
    Review Days
    26

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    Basic Information

    Device Name
    EMS PIEZON MASTER 600
    K Number
    K022328
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electro Medical Systems SA
    Date Received
    July 18, 2002
    Decision Date
    August 13, 2002
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by Electro Medical Systems SA

    K Number Device Name
    K022119 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
    K012445 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
    K002484 EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
    K992251 SWISS LITHOCLAST MULTIPURPOSE PROBE
    K963285 EMS SWISS LITHOCLAST LITHOTRIPTER
    K964111 LITHOVAC SUCTION/ASPIRATION PROBE
    K953026 MINIPIEZON
    K951531 SWISS LITHOCLAST LITHOTRIPTER