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

    TITAN SEPARATING SPRING

    K Number: K930202 · Decision May 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    133

    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
    TITAN SEPARATING SPRING
    K Number
    K930202
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ortho Spectrum, Inc.
    Date Received
    January 14, 1993
    Decision Date
    May 27, 1993
    Product Code
    DZC
    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
    DZC Wire, Orthodontic

    Similar 510(k) Clearances

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

    HYPERELASTIC WIRE

    FDA 510(k)
    FDA Class 1 ·Dental

    HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    NITINOL, NITI

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAURUM STEEL LIGATURE WIRES

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAURUM WIRES

    FDA 510(k)
    FDA Class 1 ·Dental

    FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE

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

    Other Clearances by Ortho Spectrum, Inc.

    K Number Device Name
    K890962 ORTHOPAEDIC STAPLES