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

    Midmark Dental Delivery System

    K Number: K251626 · Decision Nov 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    6
    Review Days
    159

    Basic Information

    Device Name
    Midmark Dental Delivery System
    K Number
    K251626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Midmark Corporation
    Date Received
    May 28, 2025
    Decision Date
    November 3, 2025
    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.

    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

    Firstar Dental Unit

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

    Other Clearances by Midmark Corporation

    K Number Device Name
    K253196 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
    K233026 Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
    K201667 Midmark Extraoral Imaging System (EOIS)
    K163337 Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
    K161909 IQvitals Zone