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

    THE VIVACARE T.P.S. PROBE

    K Number: K944848 · Decision Dec 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    8
    Applicant Total
    10
    Review Days
    75

    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
    THE VIVACARE T.P.S. PROBE
    K Number
    K944848
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rms Div.
    Date Received
    September 30, 1994
    Decision Date
    December 14, 1994
    Product Code
    EIX
    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
    EIX Probe, Periodontic

    Similar 510(k) Clearances

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

    VIP VICTOR INTERACTIVE PROBE

    FDA 510(k)
    FDA Class 1 ·Dental

    PROBE TIP/PERI PROBE/PERI PROBE COMP.

    FDA 510(k)
    FDA Class 1 ·Dental

    ALBUMIN REAGENT

    FDA 510(k)
    FDA Class 1 ·Dental

    ACCUTEK PERIODONTAL PROBE

    FDA 510(k)
    FDA Class 1 ·Dental

    FLORIDA PROBE

    FDA 510(k)
    FDA Class 1 ·Dental

    ACCUDENT ACCUPROBE

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

    Other Clearances by Rms Div.

    K Number Device Name
    K963367 RMS K-WIRE
    K954438 SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
    K944557 DW250 #91
    K941625 DW234 #29
    K902403 ELITE R/F SPOT FILM DRIVE
    K902146 SFD-035 SPOT FILM DEVICE
    K896665 EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
    K896119 RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
    K896324 ELITE 1500 RADIOGRAPHIC TILTING TABLE