BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LOW & HIGH SPEED KIT

    K Number: K090055 · Decision Oct 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    292

    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
    LOW & HIGH SPEED KIT
    K Number
    K090055
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dpm USA Corp.
    Date Received
    January 8, 2009
    Decision Date
    October 27, 2009
    Product Code
    EFA
    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
    EFA Handpiece, Belt And/Or Gear Driven, Dental

    Similar 510(k) Clearances

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

    Dental Handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    SMARTmatic

    FDA 510(k)
    FDA Class 1 ·Dental

    MASTERmatic LUX

    FDA 510(k)
    FDA Class 1 ·Dental

    RDT3 HANDPIECE HEAD MODEL RDT3

    FDA 510(k)
    FDA Class 1 ·Dental

    ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE

    FDA 510(k)
    FDA Class 1 ·Dental

    INTRA LUX HEAD 3 LDSY

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Dpm USA Corp.

    K Number Device Name
    K083059 AIR SONIC SCALER