BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    TRIOS Dx (R1)

    K Number: K260082 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    88

    Basic Information

    Device Name
    TRIOS Dx (R1)
    K Number
    K260082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3Shape TRIOS A/S
    Date Received
    January 12, 2026
    Decision Date
    April 10, 2026
    Product Code
    SHQ
    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
    SHQ Dental Image Analyzer, In-Office

    Other Clearances by 3Shape TRIOS A/S

    K Number Device Name
    K242103 TRIOS Ready Tip
    K221249 L1P-1F (TRIOS 5)