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

    THERMAL PULP TESTER

    K Number: K940260 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    21
    Applicant Total
    14
    Review Days
    45

    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
    THERMAL PULP TESTER
    K Number
    K940260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1720
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    January 21, 1994
    Decision Date
    March 7, 1994
    Product Code
    EAT
    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
    EAT Tester, Pulp

    Similar 510(k) Clearances

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

    THERMIQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    ELEMENTS DIAGNOSTIC UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

    FDA 510(k)
    FDA Class 2 ·Dental

    CHILLIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDO ANALYZER, MODEL 8005, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDO ANALYZER, MODEL 8005

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

    Other Clearances by Union Broach, Div. Moyco Industries, Inc.

    K Number Device Name
    K962733 CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
    K950365 MOYCO-EDTA
    K941574 RETRO MIRROR
    K935542 NICKEL-TITANIUM K-TYPE FILE
    K931742 INJECT-R FILL
    K923661 QUADRASORB FILTER
    K895174 UNION BROACH BLEACHING LIGHT
    K855136 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE
    K852474 UNION BROACH BLEACHING LIGHT
    K823489 ENDODONTIC BROACH-BARBED BROACH
    Search all 14 clearances from Union Broach, Div. Moyco Industries, Inc. →