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

    ULTRASONIC SCALER COVER

    K Number: K884221 · Decision Mar 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    162

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    Basic Information

    Device Name
    ULTRASONIC SCALER COVER
    K Number
    K884221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Steri-Shield Products, Inc.
    Date Received
    October 6, 1988
    Decision Date
    March 17, 1989
    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 Steri-Shield Products, Inc.

    K Number Device Name
    K884223 DENTAL LAMP HANDLE COVER
    K884220 AIR WATER SYRINGE TIP SHIELD
    K884219 BRACKET TABLE ARM COVER
    K884222 CURING LIGHT COVER