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

    RISKONTROL SINGLE USE

    K Number: K923876 · Decision Apr 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    245

    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
    RISKONTROL SINGLE USE
    K Number
    K923876
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Riskontrol
    Date Received
    August 3, 1992
    Decision Date
    April 5, 1993
    Product Code
    ECB
    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
    ECB Unit, Syringe, Air And/Or Water

    Similar 510(k) Clearances

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

    UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS

    FDA 510(k)
    FDA Class 1 ·Dental

    SURETIP SYRINGE TIP COVER

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTAL SYRINGE TIP

    FDA 510(k)
    FDA Class 1 ·Dental

    PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE

    FDA 510(k)
    FDA Class 1 ·Dental

    SANI-TIP

    FDA 510(k)
    FDA Class 1 ·Dental

    POSTERIOR NASAL EPISTAXIS INSTRUMENTS

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