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

    DENTAL 911

    K Number: K941066 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    442

    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
    DENTAL 911
    K Number
    K941066
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    L.A.F. Industries, Inc.
    Date Received
    March 8, 1994
    Decision Date
    May 24, 1995
    Product Code
    EMB
    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
    EMB Zinc Oxide Eugenol

    Similar 510(k) Clearances

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

    Provicol QM Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    TEMPOCEM

    FDA 510(k)
    FDA Class 1 ·Dental

    PROVISA CEM

    FDA 510(k)
    FDA Class 1 ·Dental

    NON-EUGENOL TEMPORARY CEMENT

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTIMEDIC DENTAL EMERGENCY KIT

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