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

    ORTHO-ICE

    K Number: K960799 · Decision May 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    72

    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
    ORTHO-ICE
    K Number
    K960799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1720
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultimate Wireforms, Inc.
    Date Received
    February 27, 1996
    Decision Date
    May 9, 1996
    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 Ultimate Wireforms, Inc.

    K Number Device Name
    K924805 ORTHODONTIC ARCH WIRE
    K923837 DIMPLED MULTI MODULUS ARCH WIRE
    K923836 .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING
    K923838 THE ULTIMATE RCS ARCH WIRE
    K923839 NITINOL GENTLE TOUCH COIL SPRING