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

    XP TECHNOLOGY ULTRASONIC SCALER

    K Number: K042972 · Decision Mar 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    141

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    XP TECHNOLOGY ULTRASONIC SCALER
    K Number
    K042972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Eagle Instruments, Inc.
    Date Received
    October 28, 2004
    Decision Date
    March 18, 2005
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ELC), ordered by most recent decision date.

    Varios Combi Pro2

    FDA 510(k)
    FDA Class 2 ·Dental

    GBT Machine Airflow Prophylaxis Master

    FDA 510(k)
    FDA Class 2 ·Dental

    VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

    FDA 510(k)
    FDA Class 2 ·Dental

    Integrated Endo System (Meet Endo-II)

    FDA 510(k)
    FDA Class 2 ·Dental

    OdneClean

    FDA 510(k)
    FDA Class 2 ·Dental

    Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by American Eagle Instruments, Inc.

    K Number Device Name
    K122501 AEI DR. TERAUCHI ULTRASONIC TIPS