BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    iOrtho

    K Number: K223518 · Decision Jun 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    202

    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
    iOrtho
    K Number
    K223518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai EA Medical Instruments Co., Ltd.
    Date Received
    November 23, 2022
    Decision Date
    June 13, 2023
    Product Code
    PNN
    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
    PNN Orthodontic Software

    Similar 510(k) Clearances

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

    LingOral Dental Design System

    FDA 510(k)
    FDA Class 2 ·Dental

    SureSmile Software

    FDA 510(k)
    FDA Class 2 ·Dental

    SmileInspector

    FDA 510(k)
    FDA Class 2 ·Dental

    Celebrace Software

    FDA 510(k)
    FDA Class 2 ·Dental

    Laon Ortho

    FDA 510(k)
    FDA Class 2 ·Dental

    Progressive Orthodontics App

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