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

    VIVID, MODELS 40-A0001, 40-A0004, 40-A0006

    K Number: K090079 · Decision May 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    5
    Review Days
    109

    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
    VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
    K Number
    K090079
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Progeny, Inc.
    Date Received
    January 12, 2009
    Decision Date
    May 1, 2009
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

    Similar 510(k) Clearances

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

    Midmark Dental Delivery System

    FDA 510(k)
    FDA Class 1 ·Dental

    K5 Cart, K5 Mount, K5 Swing

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Units

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BDC Dental Unit

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

    Other Clearances by Progeny, Inc.

    K Number Device Name
    K070664 PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
    K043092 PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
    K041831 PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
    K020070 JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002