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

    TOUCH-N-HEAT MODEL 5001

    K Number: K823486 · Decision Jan 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    56

    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
    TOUCH-N-HEAT MODEL 5001
    K Number
    K823486
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Analytic Technology
    Date Received
    November 23, 1982
    Decision Date
    January 18, 1983
    Product Code
    EKM
    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
    EKM Gutta-Percha

    Similar 510(k) Clearances

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

    EI DOWNPAK BARRIER SLEEVES

    FDA 510(k)
    FDA Class 1 ·Dental

    DOWN PAK

    FDA 510(k)
    FDA Class 1 ·Dental

    TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

    FDA 510(k)
    FDA Class 1 ·Dental

    ENDO TWINN

    FDA 510(k)
    FDA Class 1 ·Dental

    FIBERFILL SGP

    FDA 510(k)
    FDA Class 1 ·Dental

    ANTIBACTERIAL GUTTA PERCHA

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

    Other Clearances by Analytic Technology

    K Number Device Name
    K921604 TOUCH N' HEAT, MODIFICATION
    K915243 TOUCH 'N HEAT MODEL 5002, MODIFICATION
    K890735 COATED APEX PROBE
    K864500 ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
    K832179 HOT PROBE MODEL 6001
    K820598 HOT & COLD PULP TESTER #4001
    K801974 ANALYTIC TECH. METAL POINT HEATER #3001
    K790799 PULPTESTER MODEL 2001