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

    MuReva OM™

    K Number: DEN240077 · Decision Nov 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    338

    Basic Information

    Device Name
    MuReva OM™
    K Number
    DEN240077
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    872.5595
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Mureva Phototherapy, Inc.
    Date Received
    December 23, 2024
    Decision Date
    November 26, 2025
    Product Code
    SGQ
    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
    SGQ Intraoral Phototherapy Device