BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    tmCMF Solution

    K Number: K231520 · Decision Oct 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    130

    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
    tmCMF Solution
    K Number
    K231520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techmah Cmf
    Date Received
    May 25, 2023
    Decision Date
    October 2, 2023
    Product Code
    DZJ
    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
    DZJ Driver, Wire, And Bone Drill, Manual

    Similar 510(k) Clearances

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

    VSP System (Titanium Palatal Splint)

    FDA 510(k)
    FDA Class 2 ·Dental

    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

    FDA 510(k)
    FDA Class 2 ·Dental

    TECHFIT DISRP® System

    FDA 510(k)
    FDA Class 2 ·Dental

    TECHFIT DISRP® System

    FDA 510(k)
    FDA Class 2 ·Dental

    MedCAD AccuPlan System

    FDA 510(k)
    FDA Class 2 ·Dental

    EmbedMed

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Techmah Cmf

    K Number Device Name
    K233874 tmCMF Solution