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

    DENTAL ULTRASONIC SCALER INSERTS

    K Number: K953919 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    8
    Review Days
    47

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    Basic Information

    Device Name
    DENTAL ULTRASONIC SCALER INSERTS
    K Number
    K953919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hu-Friedy Mfg. Co., Inc.
    Date Received
    August 21, 1995
    Decision Date
    October 7, 1995
    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 Hu-Friedy Mfg. Co., Inc.

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