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

    IMPROVED DENTAL OPERATING LIGHT

    K Number: K920017 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    60

    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
    IMPROVED DENTAL OPERATING LIGHT
    K Number
    K920017
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Den-Tal-Ez Mfg Co., Inc.
    Date Received
    January 2, 1992
    Decision Date
    March 2, 1992
    Product Code
    KLC
    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
    KLC Chair, Dental, With Operative Unit

    Similar 510(k) Clearances

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

    Luvis Chair (LC700C)

    FDA 510(k)
    FDA Class 1 ·Dental

    DCI Edge Dental Chair with Operative Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

    FDA 510(k)
    FDA Class 1 ·Dental

    OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR

    FDA 510(k)
    FDA Class 1 ·Dental

    PROSTYLE COMPACT

    FDA 510(k)
    FDA Class 1 ·Dental

    ULTIMA 2 DENTAL CHAIR

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

    Other Clearances by Den-Tal-Ez Mfg Co., Inc.

    K Number Device Name
    K925629 ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
    K932824 EVACUATOR, ORAL CAVITY
    K931204 AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)
    K920016 IMPROVED DENTAL CHAIR
    K874294 AUTOCHUCK ATTACHMENT
    K780469 PANORAMIC X-RAY, DENTAL