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

    ENDOCENTER

    K Number: K131151 · Decision Jan 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    11
    Review Days
    268

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    Basic Information

    Device Name
    ENDOCENTER
    K Number
    K131151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Satelec - Acteon Group
    Date Received
    April 23, 2013
    Decision Date
    January 16, 2014
    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 Satelec - Acteon Group

    K Number Device Name
    K233922 SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
    K172137 PIEZOTOME CUBE
    K131906 SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
    K132322 NEWTRON P5 XS B.LED
    K132267 NEWTRON P5, NEWTRON P5 B.LED
    K131997 NEWTRON BOOSTER
    K113430 PROULTRA PIEZO ULTRASONIC
    K111623 I-ENDO DUAL
    K072030 IMPLANT CENTER
    K071424 PMAX NEWTRON XS
    Search all 11 clearances from Satelec - Acteon Group →