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

    RUBBER DAM HOLDER

    K Number: K781520 · Decision Oct 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    2
    Applicant Total
    16
    Review Days
    39

    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
    RUBBER DAM HOLDER
    K Number
    K781520
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    September 1, 1978
    Decision Date
    October 10, 1978
    Product Code
    EJE
    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
    EJE Frame, Rubber Dam

    Similar 510(k) Clearances

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

    HYGIENIC RUBBER DAM FRAME

    FDA 510(k)
    FDA Class 1 ·Dental

    HYGIENIC 5 & 6 RUBBER DAM FRAME

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

    Other Clearances by Young Dental Manufacturing Co. 1, LLC

    K Number Device Name
    K241041 Silver Fluoride Hypersensitivity Varnish
    K201127 DEFEND Ear-loop Face Masks
    K171377 Young INFINITY Cordless Handpiece System
    K153334 Oral-B 5% Sodium Fluoride Varnish
    K932255 YOUNG D'GRANULATOR
    K903284 YOUNG PROPHY SYSTEM, PS UNIT
    K875340 JETPOLISHER(TM)
    K875339 JETPOLISHER AIRPOLISHING POWDER
    K821484 DAWN LOW SPEED HANDPIECE SYSTEM
    K790723 PROPHYLAXIS CUPS AND POLISHERS
    Search all 16 clearances from Young Dental Manufacturing Co. 1, LLC →